tag:blogger.com,1999:blog-6943806032753082552023-11-15T22:40:14.719-08:00Goodwin BiotechnologyWhether you are developing a mammalian cell culture-derived Monoclonal Antibody, Recombinant Protein, or Vaccine, you should consider Goodwin Biotechnology as your development and cGMP manufacturing partner. We offer a full range of mammalian cell culture services ranging from the creation of up and downstream processes sufficient for the manufacturing of proof of concept, toxicology product material and processes for licensed manufacturing. Please visit www.goodwinbio.com for more information.
Anonymoushttp://www.blogger.com/profile/09780487138329762497noreply@blogger.comBlogger17125tag:blogger.com,1999:blog-694380603275308255.post-88857777551868211122016-08-14T10:02:00.000-07:002016-08-14T10:02:05.868-07:00New and Improved Goodwin Biotechnology Upstream Manufacturing Department Assets<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="font-family: Verdana, sans-serif;">As the 2016 Spring Season passaged into the summer, a new culture was seeded Upstream Manufacturing at <a href="http://www.goodwinbio.com/" target="_blank">Goodwin Biotechnology</a>, as a 200L Single Use Bioreactor (SUB) and Alternating Tangential Flow (ATF) Perfusion System was added to our Upstream Operational capacity.</span><br />
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<span style="font-family: Verdana, sans-serif; line-height: 18.4px;">The Upstream Manufacturing Team from Goodwin and representatives from Repligen Corporation and GE Healthcare huddled to flip the switch and start the operations and training on the new Systems. Working together the system manufacturers provided familiarity and crossover with the Large Scale Stirred Tank Reactor (STR) systems that are currently in house.</span><br />
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Anonymoushttp://www.blogger.com/profile/09780487138329762497noreply@blogger.com0tag:blogger.com,1999:blog-694380603275308255.post-77900239932462931392015-05-19T09:37:00.001-07:002015-05-19T09:37:18.985-07:00Highly Specialized Fill and Finish<div class="MsoNormal">
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%;">For more than 20 years,<a href="http://www.goodwinbio.com/"> <b>Goodwin Biotechnology</b></a><b> </b>has
developed into a uniquely qualified CDMO that provides a Single Source
Solution™ for clients by offering cell
line development, exploratory proof-of-concept
projects through</span><span style="font-size: 10.0pt; line-height: 107%; mso-bidi-font-family: Arial;"> </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%;">Process Development and cGMP
manufacturing of monoclonal antibodies, recombinant proteins, vaccines, and
biologic drug conjugates including antibody drug conjugates (ADCs) for small
startup ventures to large, multi-national companies as well as government agencies
and medical institutions for early and late stage clinical trials. As part of
their integrated services offerings, Goodwin Biotechnology operates an
ISO5 cGMP filling suite that can accommodate liquid filling of a wide range of
configurations to meet specific and unique client requirements. <o:p></o:p></span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%;">Goodwin Biotechnology has successfully completed
numerous traditional Fill / Finish and Drug Product manufacturing projects, as
well as customized, specialized Fill / Finish projects for small volume fills,
light sensitive products, and extremely fragile biological drugs for which
large-scale, automated fill systems are not appropriate. <o:p></o:p></span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%;">Most recently, Goodwin Technology was selected to
complete a novel Fill/Finish project, as well as Quality release and stability
testing for a cancer vaccine that is based on the Human Aspartyl (Asparaginyl)
β-Hydroxylase (HAAH) tumor-specific protein. This was geared towards enabling
Phase I clinical trials in patients suffering from various solid tumor cancers.
Panacea Pharmaceuticals, which partnered with Goodwin in this project,
described the Goodwin Biotechnology staff as extremely responsive, flexible,
and solutions oriented. It is easy to see why many companies prefer to work
with Goodwin Biotechnology on their biological projects. <o:p></o:p></span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%;">Goodwin Technology has a fill operation that is
fully validated for batch fills up to 2,000 vials per shift and volumes of
0.5mL to 10.0mL per vial. Additional features offered include:<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpFirst" style="mso-list: l0 level1 lfo1; text-indent: -.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12.0pt; line-height: 107%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-stretch: normal; line-height: normal;">
</span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%;">Utilization of a programmable pump and
manual fill nozzle (semi-automation) to provide improved yields for small lot
sizes.<o:p></o:p></span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoListParagraphCxSpMiddle" style="mso-list: l0 level1 lfo1; text-indent: -.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12.0pt; line-height: 107%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-stretch: normal; line-height: normal;">
</span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%;">Vial stoppering immediately after
filling by a second operator before removal from the fill room.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="mso-list: l0 level1 lfo1; text-indent: -.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12.0pt; line-height: 107%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-stretch: normal; line-height: normal;">
</span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%;">Fill checks that are performed at
predetermined levels. For all acceptable fill volumes, this semi-automated
process has consistently met all set standards.<o:p></o:p></span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
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<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12.0pt; line-height: 107%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-stretch: normal; line-height: normal;">
</span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%;">Observation and environmental monitoring
of all fill operations by Quality personnel.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpLast" style="mso-list: l0 level1 lfo1; text-indent: -.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 12.0pt; line-height: 107%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-stretch: normal; line-height: normal;">
</span></span><!--[endif]--><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%;">Monitoring of sealing and fill checks by
Quality personnel.<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpLast" style="mso-list: l0 level1 lfo1; text-indent: -.25in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%;">What’s more, Goodwin Biotechnology has
lyophilization capabilities for small- to mid-scale runs for both GMP and non-GMP
projects, and can accommodate a wide range of vial sizes and configurations. In
addition, Goodwin Biotechnology has successfully provided lyophilization
services for a multinational company to supply GMP material to test a commercially
available product.<o:p></o:p></span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%;">Goodwin Biotechnology has an impressive track record
of providing solutions that are customized and tailored to meet specific client
needs. It has in place a comprehensive infrastructure that is required to
deliver quality solutions, such as ready-for-clinical-trials, Final Vialed
Product (FVP). On top of the infrastructure, the team members at Goodwin Biotechnology
are highly skilled and experienced, and as a team, place a great level of
emphasis on quality and being responsive to clients’ needs in an effort to
enhance the value of their drug candidates. <o:p></o:p></span></div>
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<br />
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%;">Goodwin Biotechnology is the partner to trust for
all y<a href="https://www.blogger.com/null" name="_GoBack"></a>our biological process development, cGMP
manufacturing, as well as traditional and highly specialized fill and finish needs.
Look no further, Goodwin Biotechnology has you covered. <o:p></o:p></span></div>
Anonymoushttp://www.blogger.com/profile/09780487138329762497noreply@blogger.com0tag:blogger.com,1999:blog-694380603275308255.post-64150871354593763572015-03-24T11:56:00.003-07:002015-03-24T11:57:41.339-07:00Downstream Purification Expertise is Critical<!--[if gte mso 9]><xml>
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<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjEbofoqD938FCEP35U2gH94-yi3eGTIk72kSPmPLeHdMVWUZj262_4ypRSzm8QetWtDgSUOOTUYWKqFvrtqialIOhFYX810h8RYOmcXZb2QtRuUgF5_-ijr42oJCfMJdI290bEO9OFVMc/s1600/Goodwin+Biotech.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjEbofoqD938FCEP35U2gH94-yi3eGTIk72kSPmPLeHdMVWUZj262_4ypRSzm8QetWtDgSUOOTUYWKqFvrtqialIOhFYX810h8RYOmcXZb2QtRuUgF5_-ijr42oJCfMJdI290bEO9OFVMc/s1600/Goodwin+Biotech.jpg" height="320" width="226" /></a></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman","serif"; font-size: 14.0pt; line-height: 115%;">Process
Development</span></b></div>
<div class="MsoNormal">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;"><a href="http://www.goodwinbio.com/">Goodwin Biotechnology's</a> downstream process
development group has well over 50 years of experience in developing and
refining purification processes for recombinant proteins. With an extensive
background in the purification of proteins from mammalian, as well as plant and
animal transgenic systems, Goodwin Biotechnology can quickly develop
a purification process for clients that will maximize yields for the target
molecule, meet required purity levels, and be compliant with the regulatory
requirements for product's development status.</span></div>
<div class="MsoNormal">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;"></span></div>
<a name='more'></a><br />
<br />
Goodwin Biotechnology has a broad range of experience with the
following:<br />
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">-<span style="mso-spacerun: yes;"> </span>Monoclonal
Antibodies, Antibody Fragments (including IgG, IgA and IgM subclasses)</span></div>
<div class="MsoNormal">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">-<span style="mso-spacerun: yes;"> </span>Recombinant
Proteins</span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">-<span style="mso-spacerun: yes;"> </span>Growth
Factors, Cytokines</span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">-<span style="mso-spacerun: yes;"> </span>Hormones,
Enzymes</span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">-<span style="mso-spacerun: yes;"> </span>Antibody
Conjugates</span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">-<span style="mso-spacerun: yes;">
</span>Radio-labeled Antibodies</span><br />
</div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">Goodwin Biotechnology has experience with
affinity, ion exchange, hydrophobic interaction, mixed mode, MEP
chromatography, and other processes. Our experience includes UF processes using
TFF technologies in both flat plate and hollow fiber formats. Viral clearance
techniques employed include low pH inactivation and nanofiltration. We work
closely with filtration media providers to develop a filtration process that
works within the confines of your process and product requirements and provides
the necessary viral removal.</span><br />
</div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">cGMP
Manufacturing</span></b></div>
<div class="MsoNormal">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">As the product proceeds through its clinical
evaluation, Goodwin Biotechnology can optimize and refine the purification
process including the testing and establishment of parameter limits. When the
product reaches Phase III clinical testing and beyond, Goodwin Biotechnology
will have developed a process that can be transferred for commercial manufacturing
and ready for qualification runs with a minimum of problems.</span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">-<span style="mso-spacerun: yes;"> </span>Develop
product quality, process economics, and scalability</span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">-<span style="mso-spacerun: yes;"> </span>Resin-reuse
(e.g., Protein A column)</span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">-<span style="mso-spacerun: yes;"> </span>Product
safety and compliant (e.g., viral inactivation and removal)</span></div>
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<br /></div>
<div class="MsoNormal">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">Viral clearance studies are managed by Goodwin
Biotechnology using a contract biological safety testing organization. Viral
Clearance Studies for early stage clinical trials require two model viruses.
For late stage clinical trials, four model viruses are required.<br />
<br />
Goodwin Biotechnology can perform the necessary scale-down validation to assure
that the process transferred to the testing organization is representative of
the full-scale process. Goodwin Biotechnology can provide an onsite scientist
at the testing organization to assure that your process is run according to its
requirements to avoid comparability questions on the results. The scale down
validation and viral clearance studies are assembled into one package for
submission to regulatory agencies or other manufacturers.</span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">Besides being highly efficient on the technical
front, Goodwin Biotechnology also offers great client support, ensuring that
every client gets the personal attention of senior managers. The fact that
Goodwin Biotechnology is small enough to allow this is of great comfort, as the
sensitive process development requires that the client and the company keep all
lines of communication open in order to achieve success. If you are in search
of a company that takes competency, consistency and service delivery serious,
Goodwin Technology is the company for the job. Your hand will be held through
the entire process, your concerns attended to and at the end of it all, the
biotechnology feat that you had hoped to accomplish will be yours to keep.
Whether on an individual or corporate basis, Goodwin Technology is available to
attend to you. </span></div>
Anonymoushttp://www.blogger.com/profile/09780487138329762497noreply@blogger.com0tag:blogger.com,1999:blog-694380603275308255.post-80823614454369071862015-02-15T10:07:00.002-08:002015-02-15T10:12:03.383-08:00ENHANCING ADCs TO TARGET DISEASED CELLS AND DELIVER PAYLOADS<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhJvKw-q_bOH086BNqSSxTzr5aHsSwCsAjuNyo2El-0dcNfjkCwWhUXVta2QjcmlX4lOLX4vekkhJj1JXBFXh2bQ7dWYy3vGpvEQWNbSclZYTha9oXbeojNBwdUEtUVxp3AbT4GrfdSRqM/s1600/goodwin11111.jpeg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhJvKw-q_bOH086BNqSSxTzr5aHsSwCsAjuNyo2El-0dcNfjkCwWhUXVta2QjcmlX4lOLX4vekkhJj1JXBFXh2bQ7dWYy3vGpvEQWNbSclZYTha9oXbeojNBwdUEtUVxp3AbT4GrfdSRqM/s1600/goodwin11111.jpeg" height="320" width="226" /></a></div>
<i><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">Insulin-like growth factor</span></i><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;"> or IGF is a natural growth hormone, which plays an important
role in normal growth and development. Six soluble insulin-like growth
factor-binding proteins or IGFBPs and IGFBP proteases regulate its actions.
These binding proteins bind to Insulin-like growth factor with high affinity
and specificity[1].<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;"></span></div>
<a name='more'></a><br />
Based on their current level of understanding of the
mechanisms of action, scientists have shown that these IGFBPs are involved
actions beyond their endocrine role in IGF transport. In the pericellular and
intracellular compartments, for example, IGFBPs are instrumental in the
regulation of cell growth and survival.<br />
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<br /></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<b><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">IGF and Cancer</span></b><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;"><o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">Over the last decade, IGF has gained tremendous
interest because it plays an important role in cancer. Conventional
chemotherapy for the treatment of patients with cancer has limited specificity
for cancer cells. In these cases, high doses of systemic chemotherapy used to
treat patients have limited success and these patients experience significant
side effects. <o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<br /></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">With the shift towards targeted therapies, a number of
strategies have been exploited to target tumors directly. The most common of
these strategies involves engineered antibodies or antibody fragments. The
increased interest in IFG and cancer and this drive to targeted therapies, has
resulted in strategies targeting various components of the IGF system [2].<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<br /></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<i><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">Insulin-like growth factor-1 receptor or IGF-1R activation</span></i><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;"> is involved in cell regulation, survival and proliferation. In
advanced cancers IGF-IRs are frequently genetically altered involving mutation,
chromosomal translocation, abnormal stimulation, and loss of genomic
imprinting. High levels of IGF-1 have been reported in several cases of breast
and prostate cancers[1][2].<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<br /></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<b><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">Insulin-like growth factor-binding protein-3</span></b><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;"><o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<i><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">Insulin-like growth factor-binding protein-3</span></i><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;"> or IGFBP‐3, first isolated, characterized, and quantitated in
human plasma, in 1986, is the main IGF transport protein in the bloodstream
directly influencing IGF action. [3][4] Via independent mechanisms involving
interactions with plasma, extracellular matrices and cell surface molecules,
conditional proteolysis, cellular uptake, and nuclear transport, IGFBP-3 also
modulates IGF actions indirectly[5].<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<br /></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">IGFBP-3, which in plasma is known to participate in
high-affinity interactions with the iron-binding proteins <i>lactoferrin</i> and <i>transferrin</i>,
has been implicated with a variety of proteins or signaling cascades critical
to cell cycle control and apoptosis.<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<br /></div>
<div class="MsoNormal" style="margin-left: -49.5pt; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">Antiproliferative and proapoptotic effects of IGFBP-3,
independent from IGF/IGF-IR, contribute to improving the pathophysiology of a
variety of human diseases, such as cancer, as well as diabetes, and
malnutrition[6][7][8].<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -49.5pt; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<br /></div>
<div class="MsoNormal" style="margin-left: -49.5pt; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<b><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">Metal-binding transporter domain</span></b><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;"><o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -49.5pt; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">The amino acid metal-binding transporter domain or MBD
derived from IGFBP‐3 selectively targets cancer cells. In a number of studies
scientists have demonstrated that MBD-tagged anti-cancer peptides can have
cytotoxic effects on a broad range of human cancer cell lines. In one of these
studies, researchers investigated the discriminant validity of the molecules as
potential co-therapeutic agents. By comparing their cytotoxicity to cancer cell
lines versus normal human cell counterparts, the researchers demonstrated
synergies between these molecules and marginally cytotoxic levels of
5-fluorouracil[6].<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -49.5pt; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<br /></div>
<div class="MsoNormal" style="margin-left: -49.5pt; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">Biodistribution data from <i>in-vivo</i> experiments
in normal mice and rats further confirmed that MBD-tagged moleculespreferentially
localize to specific tissues including the kidney and pancreas and
significantly reduced splenomegaly and bone marrow cancer cell burden in
diseased animals. This suggests that MBD-tagged molecules can be used as highly
selective chemosensitizers in the treatment of hematological and disseminated
malignancies.<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -49.5pt; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<br /></div>
<div class="MsoNormal" style="margin-left: -49.5pt; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<b><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">Functionalizing MBD</span></b><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;"><o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -49.5pt; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">To enhance the ability of antibody-drug conjugates to
target and deliver payloads directly to tumor cells, Goodwin Biotechnology,
Inc., a biological Contract Manufacturing Organization or CMO (Plantation, FL)
that specializes in Mammalian Cell Culture expression systems and
Bioconjugation technologies, and Transporin, Inc. (Sunnyvale, CA), a Silicon
Valley R & D company with full ownership of IP rights to a broad array of
life science technologies, have agreed to collaborate on exploring and
functionalizing Transporin’s proprietary metal-binding domain transporter
technology in the development of antibody and peptide-based biopharmaceutical
drugs.<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -49.5pt; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<br /></div>
<div class="MsoNormal" style="margin-left: -49.5pt; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">Under the terms of the agreement <b><a href="http://www.goodwinbio.com/"><span style="color: blue;">Goodwin Biotechnology</span></a> </b>has been granted a worldwide, exclusive license to utilize the proprietary
metal-binding domain of human insulin‐like growth factor binding protein‐3
conjugated to monoclonal antibodies or antibody fusion proteins, and perform
process development and manufacturing services using such conjugates for
research, evaluation, and clinical trial purposes.<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -49.5pt; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<br /></div>
<div class="MsoNormal" style="margin-left: -49.5pt; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<b><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">Significant development</span></b><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;"><o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -49.5pt; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">“This is a significant milestone for our company,”
said Karl Pinto, CEO of Goodwin Biotechnology. “We have been committed to
investing in and advancing the field of Bioconjugation for nearly 15 years, and
this collaboration enables us to offer our clients a proprietary, enabling
technology that promises to enhance the targeting ability of our clients’
antibodies, then enhance the ability for the payload to enter the target cell
where it can do its job. This unique technology is designed to enhance the
therapeutic ratio of efficacy while minimizing side effects and it may also
reduce the cost of therapy—All of which have a positive impact on the quality
of care for patients and their families.”<o:p></o:p></span></div>
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<br /></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<b><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">Proprietary peptides</span></b><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;"><o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">“Transporin has developed a transporter module
consisting of approximately 20 amino acids based on the metal‐binding domain of
IGF‐binding proteins, which form part of a new generation of proprietary
peptides,” said Desmond Mascarenhas, PhD, CEO of Transporin.<o:p></o:p></span></div>
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<br /></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">“When covalently attached to other peptides, large
proteins or small nucleic acids, the MBD transporter can deliver these
biomolecules intracellularly, differentiating between normal cells and cells
under stress, and targeting the latter. Possible targets include many types of
cancer, metabolic disease as well as autoimmune conditions. The MBD‐peptide
complex rapidly transports its cargo into cytoplasmic and nuclear compartments
of targeted cells.”<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<br /></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">“When augmenting Goodwin Biotechnology’s expertise in
Bioconjugation with our proprietary MBD peptide technology, the potential value
of the resultant conjugate is increased multi‐fold,” Mascarenhas continued.
“There are a number of applications that can be explored. For example, the MBD amino
acid sequence can be incorporated as a linker to bind to a functional
monoclonal antibody to generate an antibody‐linker‐drug conjugate. Another
option is that the MBD peptide sequence can be genetically incorporated into
the DNA sequence of a specific product to develop a unique cell line.”<o:p></o:p></span></div>
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<br /></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<b><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">Great potential</span></b><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;"><o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">Further, when linking a monoclonal antibody to a
radioactive metal, the MBD peptide sequence can be used as an excipient to bind
the metal and possibly shield the radioisotope to protect healthy cells while
the complex is in circulation while enhancing the ability of the complex to
target diseased cells via a non‐covalent interaction that doesn’t require a
significant drug change.<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<br /></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">The ability of the MBD amino acid sequence to bind to
metals, specifically nickel, cobalt, zinc, iron and possibly other metals
(including radioisotopes) may also help enhance the purification process for
difficult‐to‐purify proteinsusing metal‐affinity columns[5]. The MBD‐antibody
conjugate can be used for diagnostic purposes, for monitoring diseases and/or
as a therapeutic modality.<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<br /></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<b><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">Unmet needs require a new approach</span></b><span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;"><o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">The potential value of the MBD‐peptide technology can
best be appreciated when put in perspective. While modern medicine has made
significant strides in the treatment of a large number of human disease
conditions, including cancer, a number of diseases require advancements to
improve detection, monitoring, and treatment.<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<br /></div>
<br />
<div class="MsoNormal" style="margin-left: -1.0in; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<span style="color: #455254; font-family: "Calibri","sans-serif"; font-size: 11.0pt; mso-ascii-theme-font: major-latin; mso-bidi-font-family: Helvetica; mso-hansi-theme-font: major-latin;">Monoclonal antibodies (mAbs) conjugated with a payload
such as a drug or radioisotope are showing some promise based on their ability
to target diseased cells. However, based on the complexity of the <i>antibody:linker:payload
conjugate</i>, premature cleavage of the payload from the conjugate, inability
of the conjugate to breach the cell wall, binding to non‐target sites and/or
getting eliminated from the body prematurely, some researchers suggest that
greater than 95% of the administered dose never reaches the intracellular
target[8].<o:p></o:p></span></div>
Anonymoushttp://www.blogger.com/profile/09780487138329762497noreply@blogger.com0tag:blogger.com,1999:blog-694380603275308255.post-28839085670126427442015-01-15T07:30:00.001-08:002015-01-15T07:30:13.021-08:00An Overview of the General Cell Culture Work at Goodwin Biotechnology<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhfSkT5mCPTk_TYHs5VJhT08BUDYU4E4mx2DLRnOFsC83KLiNrzMDFf7NtlKaz-DErIxT-9rfPPPjQ2V8eV90BN_wKZTnvxG4Z6m9op6PRf8DoD0aEYwyyFOIEd0vaT1EIoj7hzoc2S1Bo/s1600/goodwin+image.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhfSkT5mCPTk_TYHs5VJhT08BUDYU4E4mx2DLRnOFsC83KLiNrzMDFf7NtlKaz-DErIxT-9rfPPPjQ2V8eV90BN_wKZTnvxG4Z6m9op6PRf8DoD0aEYwyyFOIEd0vaT1EIoj7hzoc2S1Bo/s1600/goodwin+image.jpg" height="81" width="400" /></a></div>
<div class="MsoNormal" style="line-height: 170%; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";"><a href="http://www.goodwinbio.com/">Goodwin Biotechnology</a> is a leading biological Contract Manufacturing Organization (CMO) that offers
a full range of mammalian cell culture services ranging from the creation of up
and downstream processes sufficient for the manufacturing of proof of concept,
toxicology product material and processes for licensed manufacturing. </span></div>
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<a name='more'></a><br />
<br />
Goodwin Biotechnology works with most mammalian cell lines used for
manufacturing, including CHO, NS/0, BHK, 293 as well as murine hybridomas, and
all selection systems used with these lines. They also work with several
different selection systems such as dhfr - /methotrexate CHO, mycophenolic
acid/xanthine, and G418 systems. Their experience includes surface dependent as
well as suspension culture types.<br />
<br />
Goodwin’s clients are global and include biotech startup firms, research
institutes, universities, multinational biotechnology and pharmaceutical
companies, and government institutes with projects from translational medicine
to producing materials for clinical trials<o:p></o:p><br />
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<b><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman";">C<span style="display: none; mso-hide: all;"></span>ell Line Development<o:p></o:p></span></b></div>
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<span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Goodwin
Biotechnology scientists, many of whom are PhDs, have considerable
experience in the development of cell lines for cGMP manufacturing for clinical
studies through commercial manufacturing. In addition, working with their
partners, Goodwin can develop cell lines from cDNA that you provide. Goodwin’s
partners offer their own proprietary vectors to develop cell lines that can
routinely produce up to 4g/L in CHO cell lines.<o:p></o:p></span></div>
<h2>
<b><span style="color: windowtext; font-size: 10.0pt; line-height: 150%;">Cell Banking<o:p></o:p></span></b></h2>
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<span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%;">Goodwin
Biotechnology offers a full array cell banking services for research or
manufacturing use. Manufacturing banks include seed, master, working, and post
production. All of these banks are GMP compliant and are tested based on the
current Points to Consider for cell bank testing. Goodwin Biotechnology works
closely with their clients and with our qualified contract testing
organizations to assure acceptability of all testing. Banks are prepared using
a controlled freeze rate system and are stored in -150°C mechanical freezer
systems. All bank inventories are secured and controlled by Goodwin
Biotechnology’s Quality department. Short- or long-term storage of cell banks
is provided.<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-stretch: normal; line-height: normal;">
</span></span><!--[endif]--><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%;">Research Cell Banks can be made
at Goodwin Biotechnology to carry out non-GMP process development activities.<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-stretch: normal; line-height: normal;">
</span></span><!--[endif]--><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%;">Goodwin Biotechnology produces Master
Cell Banks (MCBs) and Working Cell Banks (WCBs) in compliance with cGMP
requirements.<o:p></o:p></span></div>
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<b><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman";">Cell Culture Process Development<o:p></o:p></span></b></div>
<div class="MsoNormal" style="line-height: 170%; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Goodwin
Biotechnology will develop a robust and reproducible cell culture process for
the production of complex therapeutic protein drug candidates. Goodwin
Biotechnology has experience with a number of cell cultivation technologies
including stationary culture disposable flasks, spinners, WAVE disposable and
stirred tank bioreactors. Goodwin Biotechnology offers cell culture production
services for non-bioreactor projects.<o:p></o:p></span></div>
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Goodwin Biotechnology offers medium evaluation and adaptation to commercial
serum free formulations for your cell line. Goodwin’s goal is to increase your
line's productivity, growth performance, and/or compliance level.<o:p></o:p></span></div>
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</span></span><!--[endif]--><b><i><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Development and optimization of robust
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different types of bioreactor systems for production and process development
services for each. Goodwin works with clients to determine the optimum
bioreactor type to use for their project based on their cell expression system
and product quantities needed.<o:p></o:p></span></div>
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</span></span><!--[endif]--><b><i><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Stirred tank batch or fed-batch
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are available. With the possibility of achieving yields up to three grams per
liter, Goodwin’s bioreactors produce up to 1,500 grams per every 8 to 10 day
run.<o:p></o:p></span></div>
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</span></span><!--[endif]--><b><i><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Fibracell disk immobilized bed
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Bioreactors with cartridge surface areas ranging from 2.1 to 25.2m² are
available. The larger of these bioreactors can produce in excess of 150 grams
during a six-week production run.<o:p></o:p></span></div>
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</span></span><!--[endif]--><b><i><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Hollow fiber</span></i></b><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-stretch: normal; line-height: normal;">
</span></span><!--[endif]--><b><i><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">6 X 5L Sartorius Bioreactors</span></i></b><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">...
Goodwin Biotechnology has available small bioreactor systems of each type for
the development of specific run parameters and scaling data for the larger production
bioreactors. These small systems are also available for the production of
non-GMP material for testing and toxicology studies.<o:p></o:p></span></div>
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<b><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt; line-height: 150%; mso-fareast-font-family: "Times New Roman";">Cell Culture Process Development<o:p></o:p></span></b></div>
<div class="MsoNormal" style="line-height: 170%; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Goodwin
Biotechnology will develop a robust and reproducible cell culture process for the
production of complex therapeutic protein drug candidates. Goodwin
Biotechnology has experience with a number of cell cultivation technologies
including stationary culture disposable flasks, spinners, WAVEdisposable and
stirred tank bioreactors. Goodwin Biotechnology offers cell culture production
services for non-bioreactor projects.<o:p></o:p></span></div>
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</span></span><!--[endif]--><b><i><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Media selection and development (both
animal component and animal-free components)</span></i></b><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">...
Goodwin Biotechnology offers medium evaluation and adaptation to commercial
serum free formulations for your cell line. Their goal is to increase your
line's productivity, growth performance, and/or compliance level.<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 170%; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .25in; margin-right: 0in; margin-top: 2.25pt; mso-list: l4 level1 lfo10; tab-stops: list .5in; text-indent: -.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-stretch: normal; line-height: normal;">
</span></span><!--[endif]--><b><i><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Development and optimization of robust
and scalable processes</span></i></b><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">... Goodwin Biotechnology offers three
different types of bioreactor systems for production and process development
services for each. Goodwin works with clients to determine the optimum
bioreactor type to use for their project based on the<a href="https://www.blogger.com/null" name="_GoBack"></a>
cell expression system and product quantities needed.<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 170%; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .25in; margin-right: 0in; margin-top: 2.25pt; mso-list: l9 level1 lfo11; tab-stops: list .5in; text-indent: -.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-stretch: normal; line-height: normal;">
</span></span><!--[endif]--><b><i><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Stirred tank batch or fed-batch
bioreactor</span></i></b><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">... Stirred tank bioreactors up to 500L
are available. With the possibility of achieving yields up to three grams per
liter, Goodwin’s bioreactors produce up to 1,500 grams per every 8 to 10 day
run.<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 170%; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .25in; margin-right: 0in; margin-top: 2.25pt; mso-list: l0 level1 lfo12; tab-stops: list .5in; text-indent: -.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-stretch: normal; line-height: normal;">
</span></span><!--[endif]--><b><i><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Fibracell disk immobilized bed
perfusion bioreactors</span></i></b><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">... <br />
Bioreactors with cartridge surface areas ranging from 2.1 to 25.2m² are
available. The larger of these bioreactors can produce in excess of 150 grams
during a six-week production run.<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 170%; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .25in; margin-right: 0in; margin-top: 2.25pt; mso-list: l8 level1 lfo13; tab-stops: list .5in; text-indent: -.25in;">
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</span></span><!--[endif]--><b><i><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Hollow fiber</span></i></b><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
<br />
<div class="MsoNormal" style="line-height: 170%; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .25in; margin-right: 0in; margin-top: 2.25pt; mso-list: l1 level1 lfo14; tab-stops: list .5in; text-indent: -.25in;">
<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-stretch: normal; line-height: normal;">
</span></span><!--[endif]--><b><i><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">6 X 5L Sartorius Bioreactors</span></i></b><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">...
Goodwin Biotechnology has available small bioreactor systems of each type for
the development of specific run parameters and scaling data for the larger
production bioreactors. These small systems are also available for the production
of non-GMP material for testing and toxicology studies.<o:p></o:p></span></div>
Anonymoushttp://www.blogger.com/profile/09780487138329762497noreply@blogger.com0tag:blogger.com,1999:blog-694380603275308255.post-31909690056078986622014-12-04T07:42:00.001-08:002014-12-04T07:46:52.884-08:00Goodwin Biotechnology-- Your Single Source Solution™ for Cytotoxic ADCs<!--[if gte mso 9]><xml>
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<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhfSkT5mCPTk_TYHs5VJhT08BUDYU4E4mx2DLRnOFsC83KLiNrzMDFf7NtlKaz-DErIxT-9rfPPPjQ2V8eV90BN_wKZTnvxG4Z6m9op6PRf8DoD0aEYwyyFOIEd0vaT1EIoj7hzoc2S1Bo/s1600/goodwin+image.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhfSkT5mCPTk_TYHs5VJhT08BUDYU4E4mx2DLRnOFsC83KLiNrzMDFf7NtlKaz-DErIxT-9rfPPPjQ2V8eV90BN_wKZTnvxG4Z6m9op6PRf8DoD0aEYwyyFOIEd0vaT1EIoj7hzoc2S1Bo/s1600/goodwin+image.jpg" height="65" width="320" /></a></div>
<div class="MsoNormal" style="line-height: 150%; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Together with our collaborative
partner, </span><span style="color: windowtext; font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Coldstream Labs</span><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">, <a href="http://www.goodwinbio.com/"><b>GoodwinBiotechnology</b> </a>has the experience, expertise, and capability to develop and
manufacture highly potent CADCs from proof of concept through to non-clinical
and clinical use, late stage as well as commercial manufacturing.</span></div>
<div class="MsoNormal" style="line-height: 150%; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%;">Goodwin Biotechnology is a full-service,
customer-focused and integrated contract services provider with a pioneering
focus on the development and manufacturing of Cytotoxic Antibody Drug
Conjugates (CADCs) from cell line development or exploratory proof-of-concept
through process development, scale up, and cGMP manufacturing. </span></div>
<div class="MsoNormal" style="line-height: 150%; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%;"></span></div>
<a name='more'></a><br />
<br />
Goodwin Biotechnology leverages over 10 years of bioconjugation experience
and expertise which complements our more than 20-year history in the
development and manufacturing of mammalian cell culture-derived monoclonal
antibodies, recombinant proteins and vaccines, making us one of the most
experienced and stable contract manufacturing organizations (CMOs) in the
world. Moreover, our global customer base which includes clients from North
America, Europe as well as Asia, consists of companies ranging from academic
institutions and biotechnology startup firms to large, established,
multinational biopharmaceutical companies. Recognizing the challenges of
manufacturing complex molecules such as CADCs, Goodwin
Biotechnology will help to formulate a strategic approach to your project with
an emphasis on critical development, manufacturing, quality, regulatory and
characterization considerations.<br />
<br />
<div class="MsoNormal" style="line-height: 150%; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Whether you have already developed a
conjugation process and simply require a technology transfer or need
development of a new conjugation process, Goodwin Biotechnology will partner
with you to develop and/or optimize your Cytotoxic Antibody Drug Conjugate
(CADC) using a risk-based Quality by Design (QbD) approach.<br />
<br />
Selection of an appropriate linker is important, and Goodwin Biotechnology demonstrates
tremendous flexibility in this regard. We can:</span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: .25in; mso-list: l0 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in; text-indent: -.25in;">
<span style="font-family: Symbol; font-size: 10.0pt; line-height: 150%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt "Times New Roman";">
</span></span></span><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Utilize your proprietary linker, or</span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: .25in; mso-list: l0 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in; text-indent: -.25in;">
<span style="mso-bookmark: _GoBack;"><span style="font-family: Symbol; font-size: 10.0pt; line-height: 150%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt "Times New Roman";">
</span></span></span><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Employ our proprietary and license-free
Linker Technologies, including</span></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: .25in; mso-list: l0 level2 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 1.0in; text-indent: -.25in;">
<span style="mso-bookmark: _GoBack;"><span style="font-family: Symbol; font-size: 10.0pt; line-height: 150%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt "Times New Roman";">
</span></span></span><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Non-cleavable, thioether-based
SteadFastTM Linker Technology, or</span></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: .25in; mso-list: l0 level2 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 1.0in; text-indent: -.25in;">
<span style="mso-bookmark: _GoBack;"><span style="font-family: Symbol; font-size: 10.0pt; line-height: 150%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt "Times New Roman";">
</span></span></span><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Cleavable, disulfide- or hydrazone-based
FlexReleaseTM Linker Technology</span></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-left: .25in; mso-list: l0 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in; text-indent: -.25in;">
<span style="mso-bookmark: _GoBack;"><span style="font-family: Symbol; font-size: 10.0pt; line-height: 150%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt "Times New Roman";">
</span></span></span><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Collaborate with our partners to design
and synthesize novel, cleavable linkers based on peptide or other appropriate
linkages. </span></span></div>
<span style="mso-bookmark: _GoBack;"></span>
<br />
<div class="MsoNormal" style="line-height: 150%; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">For more information on our unique
SteadFast™ or FlexRelease™ Linker Technologies, please fill out the form below.<br />
<br />
Moreover, selection of an appropriate cytotoxic payload to which the target
cancer cell demonstrates susceptibility is critical, and Goodwin Biotechnology
will help to evaluate a payload of the appropriate potency and specificity
under the Safebridge or Merck classification systems (e.g., protein toxin,
cytotoxic peptide or small molecule cancer drug).<br />
<br />
Goodwin Biotechnology can work with cytotoxic payloads up to Safebridge Level 3
within our own facilities (e.g., doxorubicin or methotrexate); however, for
ADCs utilizing highly potent cytotoxic payloads (e.g., maytansine, auristatin,
DM4, or tubulysin) requiring a Safebridge level 4 / Merck level 5 facility, GBI
has collaborated with Coldstream Laboratories where we seamlessly execute all
conjugation processes within Coldstream’s high-containment facilities, from
proof-of-concept through late-stage clinical trials and large-scale cGMP
manufacturing or commercial products.<br />
<br />
Rest assured, whether we work onsite at GBI or offsite at our partner’s
facility, we will develop at the earliest stages a scalable, GMP-compliant,
economical and efficient process that is designed to manufacture your CADC
product in an expedient manner and meet all appropriate quality requirements relative
to safety, purity, identity, potency and immunogenicity.</span><br />
</div>
<div class="MsoNormal" style="line-height: 150%; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%;">When developing Antibody Drug Conjugates, added
consideration must be given to issues of aggregation, solubility,
precipitation, product integrity & activity as well as reaction by-products
that often play a larger role in bioconjugates as compared to unconjugated
proteins. With more than a decade of experience, we can help
overcome these technical and compliance challenges by selecting the appropriate
solvents, optimizing reaction times, and utilizing appropriate purification
processes (e.g., TFF, chromatography, and other filtration processes) that are
linearly scalable for large-scale GMP manufacturing and compliant with
regulatory guidelines<br />
<br />
Further, at an early stage during development, Goodwin Biotechnology will
perform product pre-formulation with limited stability studies to determine the
appropriate buffer pH, conductivity, excipients, and storage temperatures that
confer long-term product stability. In addition to pre-formulation development,
our collaborative partner, </span><span style="color: windowtext; font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%;">Coldstream Laboratories</span><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%;">,
can develop lyophilized formulations that are based on robust and
cost-efficient processes. Their rapid-response formulation team has experience
in screening effective combinations of solvents (both aqueous and non-aqueous),
buffers, bulking agents, and lyo/cryo-protectants. This experience leads to a
robust final product that has low residual moisture/solvent, forms a solid and
attractive cake, reconstitutes readily and completely, and resists physical and
chemical degradation.<br />
<br />
Further, </span><span style="color: windowtext; font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%;">Coldstream Laboratories</span><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%;"> offers
clinical and commercial formulation development as well as ISO 5-compliant
liquid and lyophilized Fill & Finish in a variety of container / closure
systems ranging from tens to thousands of vials depending on your needs.</span><br />
</div>
<div class="MsoNormal" style="line-height: 150%; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Comprehensive analytical
characterization is a critical element of developing and manufacturing Cytotoxic
Antibody Drug Conjugates (CADCs), and Goodwin Biotechnology will perform assay
tech transfer and verification or develop analytical methods to fully
characterize your CADC relative to potency, purity, identity, safety, quality,
and Drug to Antibody Ratio (DAR). Analytical methods must encompass
characterization of the CADC’s Critical Quality Attributes (CQA) and
quantification of product-related impurities as well as process-related
impurities. This includes determining the percentages of:</span></div>
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<br /></div>
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<span style="font-family: Symbol; font-size: 10.0pt; line-height: 150%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt "Times New Roman";">
</span></span></span><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 150%; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman";">Unreacted antibody, linker, and
cytotoxic payload</span></div>
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fragments</span></div>
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strategy to identify regulatory pathways and gain regulatory approval of your
Antibody Drug Conjugate (ADC) in accordance with the requirements of the
relevant agency (i.e., FDA, EMEA, and others).<br />
<br />
Examples of our Quality and Regulatory expertise</span></div>
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approach towards ADC development</span></div>
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Anonymoushttp://www.blogger.com/profile/09780487138329762497noreply@blogger.com0tag:blogger.com,1999:blog-694380603275308255.post-38706029109823296662014-10-29T06:44:00.004-07:002014-10-29T06:44:44.581-07:00Goodwin Biotechnology Global Customer Value Leadership Award for Mammalian Biologics Contract Manufacturing <!--[if gte mso 9]><xml>
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<b style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="font-family: "Arial","sans-serif"; mso-ansi-language: EN-GB;">Frost
& Sullivan Presents</span></b></div>
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<b style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="font-family: "Arial","sans-serif"; mso-ansi-language: EN-GB;">Goodwin
Biotechnology with the Global Customer Value Leadership Award for Mammalian Biologics
Contract Manufacturing </span></b></div>
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<i style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="font-family: "Arial","sans-serif"; font-size: 10.0pt; mso-ansi-language: EN-GB;">Goodwin Biotechnology pioneered best-in-class practices for the
development of complex Biopharmaceuticals and Antibody Drug Conjugates (ADCs) </span></i></div>
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<span lang="EN-GB" style="font-family: "Arial","sans-serif"; font-size: 10.0pt; mso-ansi-language: EN-GB;">LONDON — September 2,
2014 — <span style="mso-bidi-font-style: italic;">Based on its recent analysis of
the </span>mammalian contract manufacturing services market<span style="mso-bidi-font-style: italic;">, Frost & Sullivan recognises </span>Goodwin
Biotechnology <span style="mso-bidi-font-style: italic;">with the 2014 </span>Global
<span style="mso-bidi-font-style: italic;">Frost & Sullivan </span>Award for Customer
Value Leadership. Goodwin Biotechnology’s reputation as one of the most trusted
providers of mammalian contract manufacturing and development services has been
built on more than 20 years of experience in the bioprocess development and
cGMP manufacturing of mammalian cell culture-derived monoclonal antibodies
(mAbs), vaccines, and recombinant proteins, and more than 10 years pioneering
the field of bioconjugation.</span></div>
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<span lang="EN-GB" style="font-family: "Arial","sans-serif"; font-size: 10.0pt; mso-ansi-language: EN-GB;">Goodwin Biotechnology
championed the concept of ‘full integration’ in the biopharmaceutical contract
manufacturing space. It is a one-stop shop, offering its partners a
comprehensive range of services from cell line development and proof-of-concept
projects to bioprocess development and the manufacture of material for
preclinical / Tox studies as well as early to late phase clinical trials.</span></div>
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<span lang="EN-GB" style="font-family: "Arial","sans-serif"; font-size: 10.0pt; mso-ansi-language: EN-GB;">Goodwin Biotechnology
strives to be a highly flexible partner with its clients by finding customized
solutions for the distinctive needs of every project and ensuring smooth
implementation all throughout the lifecycle of an engagement. Furthermore, it has
enhanced its brand value on a global basis by maintaining high levels of
transparency and responsiveness while and focusing on quality, and working
within budgets and timelines.</span></div>
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<span lang="EN-GB" style="font-family: "Arial","sans-serif"; font-size: 10.0pt; mso-ansi-language: EN-GB;">The core services
offered by Goodwin Biotechnology include cell line development through
collaborations, cell culture and purification process development, cell
banking, process scale-up, engineering runs for toxicology study materials, and
strict adherence to current good manufacturing practices (cGMP) for
manufacturing and providing Fill / Finish services for biopharmaceutical <a href="https://www.blogger.com/null" name="_GoBack"></a>candidates used in human clinical trials. The company has
also established best-in-class processes for the production of antibody drug
conjugates (ADCs), cytotoxic ADCs (CADCs), antibody-chelator conjugates (for
radioimmunoconjugates) and other bioconjugates.</span></div>
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<span lang="EN-GB" style="font-family: "Arial","sans-serif"; font-size: 10.0pt; mso-ansi-language: EN-GB;">“These core services
are fully complemented and enhanced by the company’s analytical and formulation
development capabilities as well as its quality assurance, quality control,
regulatory and project management capabilities,” said Frost & Sullivan Senior
Research Analyst Aiswariya Chidambaram. “The complete and fully-integrated
services offered by Goodwin Biotechnology reduce the supply chain complexities and
timeline for clients to efficiently meet their preclinical and clinical needs.”</span></div>
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<span lang="EN-GB" style="font-family: "Arial","sans-serif"; font-size: 10.0pt; mso-ansi-language: EN-GB;">“We at Goodwin
Biotechnology are honored to be recognized for such a prestigious award, which
showcases our orientation towards providing our clients with the best overall
value proposition,” noted Karl Pinto, CEO of Goodwin Biotechnology. “It is a
testament to the company’s rich and distinguished history, coupled with its
innovative, state-of-the-art technologies, and highly skilled scientists that
enables us to meet the expectations of customers across the globe and at
various stages of their respective product development cycles. Having addressed
challenges pertaining to the manufacturing of complex biological molecules,
such as monoclonal antibodies, recombinant therapeutic proteins, vaccines and cytotoxic
ADCs (CADCs), Goodwin Biotechnology helps our clients formulate a strategic
approach with particular emphasis on critical protein product characterization,
process development, and cGMP manufacturing for regulatory compliance.”</span></div>
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<span lang="EN-GB" style="font-family: "Arial","sans-serif"; font-size: 10.0pt; mso-ansi-language: EN-GB;">“Goodwin
Biotechnology’s time-tested expertise with various host cell types and process
optimisation techniques enables seamless technology transfers between R&D
and GMP manufacturing for clinical studies,” added Chidambaram. “It is one of
the few contract manufacturing organisations to have installed capabilities for
a number of robust and reproducible cell cultivation technologies, including disposable
bioreactors such as, WAVE, perfusion, and stainless steel tank bioreactors.”</span></div>
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<span lang="EN-GB" style="font-family: "Arial","sans-serif"; font-size: 10.0pt; mso-ansi-language: EN-GB;">At the start of every
project, Goodwin Biotechnology focuses on optimising and refining the processes
to maximize productivity and ensure seamless scale up. Towards that end, the
company has hands-on experience in several chromatographic techniques including
affinity, ion exchange, hydrophobic interaction, mixed mode, and size-exclusion
chromatography. In addition, its ultrafiltration/diafiltration (UF/DF)
processes use tangential flow filtration (TFF) technologies in both flat-plate
and hollow-fiber formats.</span></div>
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<span lang="EN-GB" style="font-family: "Arial","sans-serif"; font-size: 10.0pt; mso-ansi-language: EN-GB;">Goodwin Biotechnology
also addresses complex issues associated with antibody drug conjugates,
including linker design, drug payload selection, and antibody stability in the
production of multi-gram lots of conjugated antibodies used globally in
clinical trials. Apart from its rich and varied expertise in protein
modification through chemical conjugation and enzymatic digestion methods, Goodwin
Biotechnology also offers unique specialties such as the production of Fab and
F(ab’)2 fragments and their subsequent purification as per client specifications.</span></div>
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<span lang="EN-GB" style="font-family: "Arial","sans-serif"; font-size: 10.0pt; mso-ansi-language: EN-GB;">Each year, Frost
& Sullivan presents this award to the company that has demonstrated
excellence in implementing strategies that proactively create value for its
customers with a focus on improving the return on the investment that customers
make in its services or products. The award recognises the company's inordinate
focus on enhancing the value that its customers receive, beyond simply good
customer service, leading to improved customer retention and, ultimately,
customer base expansion.</span></div>
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<span lang="EN-GB" style="font-family: "Arial","sans-serif"; font-size: 10.0pt; mso-ansi-language: EN-GB;">Frost & Sullivan
Best Practices awards recognise companies in a variety of regional and global
markets for demonstrating outstanding achievement and superior performance in
areas such as leadership, technological innovation, customer service and
strategic product development. Industry analysts compare market participants<span style="color: black;"> and measure performance through in-depth interviews,
analysis and extensive secondary research to identify best practices in the
industry.</span></span></div>
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<b style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="font-family: "Arial","sans-serif"; font-size: 10.0pt; mso-ansi-language: EN-GB;">About Goodwin Biotechnology</span></b></div>
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<b><span style="mso-bidi-font-family: Arial;">Goodwin
Biotechnology</span></b><span style="mso-bidi-font-family: Arial;"> is a
world-class CMO that offers a Single Source Solution™ through partnerships with
clients for cell line development or exploratory proof of concept projects
through process development and cGMP contract manufacturing of monoclonal
antibodies, recombinant proteins, vaccines, and Antibody Drug Conjugates (ADCs)
and other Biologic Drug Conjugates for early and late stage clinical trials. By
working with Goodwin Biotechnology, our clients can enhance the value of their
product candidates with clear development and manufacturing strategies as well
as a road map to meet the highest quality product requirements from the
milligram and gram range to kilogram quantities as the product candidates move
along the clinical approval pathway in a cost-effective, timely, and cGMP
compliant manner to enhance patients’ lives. With over 20 years of experience
as an independent contract manufacturer, Goodwin Biotechnology has worked as a
strategic partner with companies of all sizes from small university spin-offs
to major research institutes, government agencies and large, established and
multi-national biopharmaceutical companies. Additional information may be found
at </span><a href="http://www.goodwinbio.com/"><span style="mso-bidi-font-family: Arial;">http://www.GoodwinBio.com</span></a><span style="mso-bidi-font-family: Arial;">.</span></div>
Anonymoushttp://www.blogger.com/profile/09780487138329762497noreply@blogger.com0tag:blogger.com,1999:blog-694380603275308255.post-81428676343229970902014-10-02T11:17:00.003-07:002014-10-02T11:17:55.247-07:00The Highest Quality Process Development<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiRdthq9Ov_WKjNrD33hVSAkpiXx3MY0WR6wY0zVChCtpKW2pl4onLbjvOcWcLn5lRx4ucLhWvbxxeI7c2QM3UBiKgx7JgAwKEgmyWu8Jk_2bY3a15swR3csfFMgX4iaJbTsNg4S12CzWU/s1600/cell+culture.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiRdthq9Ov_WKjNrD33hVSAkpiXx3MY0WR6wY0zVChCtpKW2pl4onLbjvOcWcLn5lRx4ucLhWvbxxeI7c2QM3UBiKgx7JgAwKEgmyWu8Jk_2bY3a15swR3csfFMgX4iaJbTsNg4S12CzWU/s1600/cell+culture.jpg" /></a></div>
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<span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-fareast-font-family: "Times New Roman";">Goodwin Biotechnology will develop a
robust and reproducible cell culture <a href="http://www.goodwinbio.com/">process development </a>for the production of complex
therapeutic protein drug candidates. Goodwin Biotechnology has experience with
a number of cell cultivation technologies including stationary culture
disposable flasks, spinners, WAVE disposable and stirred tank bioreactors.
Goodwin Biotechnology offers cell culture production services for
non-bioreactor projects.<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><b><i><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">Media selection and development (both animal component and
animal-free components)</span></i></b><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-fareast-font-family: "Times New Roman";">...
Goodwin Biotechnology offers medium evaluation and adaptation to commercial
serum free formulations for your cell line. Our goal is to increase your line's
productivity, growth performance, and/or compliance level.<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><b><i><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">Development and optimization of robust and scalable
processes</span></i></b><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-fareast-font-family: "Times New Roman";">...
Goodwin Biotechnology offers three different types of bioreactor systems for
production and process development services for each. We work with clients to
determine the optimum bioreactor type to use for their project based on their
cell expression system and product quantities needed.<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="font-family: Symbol; font-size: 10.0pt; line-height: 170%; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol;">·<span style="font-family: 'Times New Roman'; font-size: 7pt; line-height: normal;">
</span></span><!--[endif]--><b><i><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">Stirred tank batch or fed-batch bioreactor</span></i></b><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-fareast-font-family: "Times New Roman";">... Stirred tank bioreactors up to
500L are available. With the possibility of achieving yields up to three grams
per liter, our bioreactors could produce up to 1,500 grams per every 8 to 10
day run.<o:p></o:p></span></div>
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</span></span><!--[endif]--><b><i><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">Fibracell disk immobilized bed perfusion bioreactors</span></i></b><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-fareast-font-family: "Times New Roman";">... </span></div>
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<span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-fareast-font-family: "Times New Roman";">BBioreactors with cartridge surface areas ranging from 2.1 to 25.2m² are
available. The larger of these bioreactors can produce in excess of 150 grams
during a six-week production run.<o:p></o:p></span></div>
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</span></span><!--[endif]--><b><i><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">6 X 5L Sartorius Bioreactors</span></i></b><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-fareast-font-family: "Times New Roman";">... Goodwin Biotechnology has
available small bioreactor systems of each type for the development of specific
run parameters and scaling data for the larger production bioreactors. These
small systems are also available for the production of non-GMP material for
testing and toxicology studies.<o:p></o:p></span></div>
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<br /></div>
<div class="MsoNormal" style="background: white; line-height: 115%; margin-bottom: 12.0pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%; mso-fareast-font-family: "Times New Roman";">Further,<span style="color: #222222;">
Goodwin Biotechnology's downstream process development group has well over 50
years of experience in developing and refining purification processes. With an
extensive background in the purification of proteins from mammalian, as well as
plant and animal transgenic systems, Goodwin Biotechnology can
quickly develop a purification process for clients that will maximize yields
for the target molecule, meet required purity levels, and be compliant with the
regulatory requirements for product's development status.<br />
<br />
Goodwin Biotechnology has a broad range of experience with the
following: <o:p></o:p></span></span></div>
<div class="MsoNormal" style="background: white; line-height: 115%; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="color: #222222; font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%; mso-fareast-font-family: "Times New Roman";"> Monoclonal
Antibodies, Antibody Fragments (including IgG, IgA and IgM subclasses)<o:p></o:p></span></div>
<div class="MsoNormal" style="background: white; line-height: 115%; margin-top: 2.25pt; mso-margin-bottom-alt: auto;">
<span style="color: #222222; font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%; mso-fareast-font-family: "Times New Roman";"> Recombinant
Proteins<o:p></o:p></span></div>
<div class="MsoNormal" style="background: white; line-height: 115%; margin-top: 2.25pt; mso-margin-bottom-alt: auto;">
<span style="color: #222222; font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%; mso-fareast-font-family: "Times New Roman";"> Growth
Factors, Cytokines<o:p></o:p></span></div>
<div class="MsoNormal" style="background: white; line-height: 115%; margin-top: 2.25pt; mso-margin-bottom-alt: auto;">
<span style="color: #222222; font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%; mso-fareast-font-family: "Times New Roman";"> Hormones,
Enzymes<o:p></o:p></span></div>
<div class="MsoNormal" style="background: white; line-height: 115%; margin-top: 2.25pt; mso-margin-bottom-alt: auto;">
<span style="color: #222222; font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%; mso-fareast-font-family: "Times New Roman";"> Antibody
Conjugates<o:p></o:p></span></div>
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<span style="color: #222222; font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%; mso-fareast-font-family: "Times New Roman";"> Radio-labeled
Antibodies<o:p></o:p></span></div>
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<div class="MsoNormal" style="background: white; line-height: 115%; margin-top: 2.25pt; mso-margin-bottom-alt: auto;">
<span style="color: #222222; font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%; mso-fareast-font-family: "Times New Roman";">Goodwin Biotechnology has experience with affinity, ion
exchange, hydrophobic interaction, mixed mode, MEP chromatography, and other
processes. Our experience includes UF processes using TFF technologies in both
flat plate and hollow fiber formats. Viral clearance techniques employed
include low pH inactivation and nanofiltration. We work closely with filtration
media providers to develop a filtration process that works within the confines
of your process and product requirements and provides the necessary viral
removal.<o:p></o:p></span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">When coming up with a
cGMP manufacturing strategy, Goodwin Biotechnology will develop a risk based
approach from the beginning to the end. We will help you to identify a target
product profile and critical product attributes. We will even help you to
develop a process control strategy and monitor the process from the beginning
to the end.<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: 115%;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;"><br /></span></div>
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 107%; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US;">Goodwin Biotechnology delivers the highest
quality materials in a very cost effective and time-sensitive manner. Goodwin
can help you to create a process design space and execute process validation. </span>Anonymoushttp://www.blogger.com/profile/09780487138329762497noreply@blogger.com0tag:blogger.com,1999:blog-694380603275308255.post-75670927052782336182014-08-19T09:26:00.001-07:002014-08-19T09:26:16.176-07:00How Radioimmunoconjugates are Used<!--[if gte mso 9]><xml>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;"><a href="http://www.goodwinbio.com/">Radioimmunoconjugates</a> (radiolabeled antibodies and
radiolabeled proteins) are a class of conjugates used primarily for
cancer/tumor imaging and therapy.<span style="mso-spacerun: yes;"> </span>They
consist of either a targeting antibody / protein directly labeled with a
radionuclide (radioisotope) such as iodine 131, or a targeting antibody /
protein conjugated to a radionuclide chelator (e.g., CHX-A, DOTA) and then
indirectly labeled with a radionuclide, e.g., indium 111 or yttrium 90 via the
chelator.<span style="mso-spacerun: yes;"> </span>Radioimmunoconjugates offer
radio-immunodiagnostic solutions at low doses of radionuclide, but can also
provide radioimmunotherapy at high doses of the radionuclide.<span style="mso-spacerun: yes;"></span>Example of FDA approved radioimmunoconjugates
include Zevalin<sup>®</sup> and Bexxar..</span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">Zevalin can be used to treat cancer patients whose
disease has relapsed after going through chemotherapy. Both Zevalin and Bexxar
are RIC therapeutic agents which can be used to help cancer patients. Before
the patient receives therapy, a bone marrow biopsy must be conducted to
ascertain that there’s an adequate bone marrow reserve. This is because both
agents can cause myelosuppression which basically leads to a reduction in white
blood cells <span style="mso-spacerun: yes;"> </span>due to excessive radiation that
can damage the bone marrow.</span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">Radioimmunoconjugates have been used in radiation
therapy which is a common treatment option for people suffering from lymphoma. During
Radioimmunoconjugate therapy the antibodies/proteins are introduced in
significantly high doses directly to the surface of the malignant lymphoma
cells in order to destroy them.<span style="mso-spacerun: yes;"> </span>The
radiation is done without affecting the healthy surrounding tissues. This form
of radiation therapy is not suitable for all cancer patients. According to the
FDA, Radioimmunoconjugate therapy is yet to be proven effective for severe
lymphoma cases. However, these antibodies have been approved in the treatment
of low grade lymphoma.</span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">Radioimmunoconjugates are safe when used in
appropriate dosages. They can even be used in experimental procedures to treat
various forms of cancer in animals. In most cases, immunoconjugates are
combined together with other agents when used in treatment.</span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">For instance, researchers have applied Radioimmunotherapy
together with immunotoxin therapy in mice in order to enhance the effectiveness
of the treatment. These studies have shown that when one form of therapy is
used alone, the procedure is safe but not curative. When both are used,
radioimmunotherapy was used before immunotoxin therapy in order to work. When
used in reverse order, the combination can become toxic or even deadly. This
just goes to show how Radioimmunoconjugates can be used in different
experimental procedures by researchers who are trying to discover the
effectiveness of these antibodies/proteins.</span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">Radioisotopes conjugated to target specific antibodies
are also used to help diagnose diseases and monitor therapy. By using
antibodies that specifically target diseased cells, the patient can be imaged
after an injection to confirm the presence of disease and / or monitor the
effectiveness of other types of treatment so that informed medical decisions
can be made. <span style="mso-spacerun: yes;"> </span></span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;"><span style="mso-spacerun: yes;"> </span>Choose high
quality radioimmunoconjugates which are made by experienced manufacturers if
you’d like to obtain reliable experimental results. Companies like Goodwin
Biotechnology have spent many years manufacturing ADCs of the highest quality
and you can rely on their products to obtain consistent results. They even
offer you a sample of their bioconjugation projects.</span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">Radioimmunoconjugates are extensively used in
research. <a href="http://www.goodwinbio.com/">Goodwin Biotechnology</a> offers high quality radioimmunoconjugates
together with other types of protein bioconjugates. They specialize in
conjugation of different antibodies/proteins with other molecules during
development and manufacturing. Goodwin Biotechnology has extensive capabilities
in providing reliable biconjugation services which includes antibody drug
conjugates (ADCs) including cytotoxic antibody drug conjugates (CADCs) and
radioimmunoconjugates among other types of bioconjugates.</span></div>
Anonymoushttp://www.blogger.com/profile/09780487138329762497noreply@blogger.com0tag:blogger.com,1999:blog-694380603275308255.post-85265073769580285502014-07-16T10:22:00.001-07:002014-07-16T10:22:03.511-07:00Goodwin Biotechnology offers a full range of mammalian cell culture services<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj9KRenT1xajp8ZbJsfC9crt6znuHVMgcW-_JzIumMObcF3oDQ-P3BHb_5UcLfWjlxMt7J185H2W92kudzwfxpecwhfocMHrBxkSVjYuUX6hcEG8qE8S6GLJH9hyMKkzpwcdy-ZeYkTkic/s1600/Goodwin+Biotech.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj9KRenT1xajp8ZbJsfC9crt6znuHVMgcW-_JzIumMObcF3oDQ-P3BHb_5UcLfWjlxMt7J185H2W92kudzwfxpecwhfocMHrBxkSVjYuUX6hcEG8qE8S6GLJH9hyMKkzpwcdy-ZeYkTkic/s1600/Goodwin+Biotech.jpg" height="320" width="226" /></a></div>
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<span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">Goodwin Biotechnology offers a full range of<a href="http://www.goodwinbio.com/cell-culture.html"> mammalian cell culture services </a>ranging from the creation of up and downstream processes sufficient for the manufacturing of proof of concept, toxicology product material and processes for licensed manufacturing.<span class="Apple-converted-space"> </span></span></div>
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<a name='more'></a><br /><br />We work with most cell lines used for manufacturing, including CHO, NS/0, BHK, 293 as well as murine hybridomas, and all selection systems used with these lines. We also work with several different selection systems such as dhfr - /methotrexate CHO, mycophenolic acid/xanthine, and G418 systems. Our experience includes surface dependent as well as suspension culture types.<span class="Apple-converted-space"> </span><br /><br />Our clients are global and include biotech startup firms, research institutes, universities, multinational biotechnology and pharmaceutical companies, and government institutes with projects from translational medicine to producing materials for clinical trials.<span style="font-family: Calibri, sans-serif; font-size: 11pt;"></span><br />
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<span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt; line-height: 22.66666603088379px;">Goodwin Biotechnology will develop a robust and reproducible cell culture process for the production of complex therapeutic protein drug candidates. Goodwin Biotechnology has experience with a number of cell cultivation technologies including stationary culture disposable flasks, spinners, WAVE disposable and stirred tank bioreactors. Goodwin Biotechnology offers cell culture production services for non-bioreactor projects.</span></div>
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<span style="font-family: Symbol; font-size: 10pt; line-height: 22.66666603088379px;"><span>·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> <span class="Apple-converted-space"> </span></span></span></span><b><i><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt; line-height: 22.66666603088379px;">Media selection and development (both animal component and animal-free components)</span></i></b><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt; line-height: 22.66666603088379px;">... Goodwin Biotechnology offers medium evaluation and adaptation to commercial serum free formulations for your cell line. Our goal is to increase your line's productivity, growth performance, and/or compliance level.</span></div>
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<span style="font-family: Symbol; font-size: 10pt; line-height: 22.66666603088379px;"><span>·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> <span class="Apple-converted-space"> </span></span></span></span><b><i><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt; line-height: 22.66666603088379px;">Development and optimization of robust and scalable processes</span></i></b><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt; line-height: 22.66666603088379px;">... Goodwin Biotechnology offers three different types of bioreactor systems for production and process development services for each. We work with clients to determine the optimum bioreactor type to use for their project based on their cell expression system and product quantities needed.</span></div>
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<span style="font-family: Symbol; font-size: 10pt; line-height: 22.66666603088379px;"><span>·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> <span class="Apple-converted-space"> </span></span></span></span><b><i><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt; line-height: 22.66666603088379px;">Stirred tank batch or fed-batch bioreactor</span></i></b><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt; line-height: 22.66666603088379px;">... Stirred tank bioreactors up to 500L are available. With the possibility of achieving yields up to three grams per liter, our bioreactors could produce up to 1,500 grams per every 8 to 10 day run.</span></div>
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<span style="font-family: Symbol; font-size: 10pt; line-height: 22.66666603088379px;"><span>·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> <span class="Apple-converted-space"> </span></span></span></span><b><i><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt; line-height: 22.66666603088379px;">Fibracell disk immobilized bed perfusion bioreactors</span></i></b><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt; line-height: 22.66666603088379px;">...<span class="Apple-converted-space"> </span><br />Bioreactors with cartridge surface areas ranging from 2.1 to 25.2m² are available. The larger of these bioreactors can produce in excess of 150 grams during a six-week production run.</span></div>
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<span style="font-family: Symbol; font-size: 10pt; line-height: 22.66666603088379px;"><span>·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> <span class="Apple-converted-space"> </span></span></span></span><b><i><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt; line-height: 22.66666603088379px;">6 X 5L Sartorius Bioreactors</span></i></b><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt; line-height: 22.66666603088379px;">... Goodwin Biotechnology has available small bioreactor systems of each type for the development of specific run parameters and scaling data for the larger production bioreactors. These small systems are also available for the production of non-GMP material for testing and toxicology studies.</span></div>
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<span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt; line-height: 22.66666603088379px;">Goodwin Biotechnology manufactures cGMP material for clients using:</span></div>
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<span style="font-family: Symbol; font-size: 10pt; line-height: 22.66666603088379px;"><span>·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> <span class="Apple-converted-space"> </span></span></span></span><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt; line-height: 22.66666603088379px;">Dakota stirred tanks, 200L and 500L.</span></div>
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<span style="font-family: Symbol; font-size: 10pt; line-height: 22.66666603088379px;"><span>·<span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> <span class="Apple-converted-space"> </span></span></span></span><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt; line-height: 22.66666603088379px;">50L disposable WAVE bioreactor</span></div>
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<span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">The scale of bioreactor selected depends on the productivity of the cell line and the requirement for GMP material. Once the GMP material is produced, Goodwin Biotechnology performs in-process and release testing as well as QA review of the GMP manufacturing documentation. In addition, Goodwin Biotechnology offers stability studies, viral clearance studies, creation of a reference standard, etc. to meet regulatory compliance needs.Please <a href="http://www.goodwinbio.com/contact-us.html">contact us.</a></span></div>
Anonymoushttp://www.blogger.com/profile/09780487138329762497noreply@blogger.com0tag:blogger.com,1999:blog-694380603275308255.post-80018823544390307192014-06-13T11:27:00.003-07:002014-06-13T11:27:49.925-07:00Understand the Cell Line Development Process<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhJvKw-q_bOH086BNqSSxTzr5aHsSwCsAjuNyo2El-0dcNfjkCwWhUXVta2QjcmlX4lOLX4vekkhJj1JXBFXh2bQ7dWYy3vGpvEQWNbSclZYTha9oXbeojNBwdUEtUVxp3AbT4GrfdSRqM/s1600/goodwin11111.jpeg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhJvKw-q_bOH086BNqSSxTzr5aHsSwCsAjuNyo2El-0dcNfjkCwWhUXVta2QjcmlX4lOLX4vekkhJj1JXBFXh2bQ7dWYy3vGpvEQWNbSclZYTha9oXbeojNBwdUEtUVxp3AbT4GrfdSRqM/s1600/goodwin11111.jpeg" height="320" width="226" /></a></div>
<a href="http://www.goodwinbio.com/cell-line-development.html"><b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US;">Cell line development</span></b></a><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US;"> is important in the manufacturing of high
quality recombinant proteins. Goodwin Biotechnology has extensive experience in
this field. In conjunction with its collaborative partners, Goodwin
Biotechnology can develop a variety of high expressing cell lines from cDNA
provided by the client</span><span style="color: #eeeded; font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 115%; mso-ansi-language: EN-US; mso-bidi-font-family: "Times New Roman"; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US;"><span style="color: black;"> </span></span><br />
<span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10pt; line-height: 115%;">that can routinely produce
up to 4g/L</span><br />
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<span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10pt; line-height: 115%;"><span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US; mso-themecolor: text1;">In order to develop a cell line successfully, a
project plan must be prepared which includes all cell line<b style="mso-bidi-font-weight: normal;"> </b>development activities. This plan will be presented to the client
for review and approval before initiating the work. There are various ways in
which cell lines can be developed.</span></span><br />
<br />
<span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10pt; line-height: 115%;"><span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US; mso-themecolor: text1;"><span style="color: black; font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 115%; mso-ansi-language: EN-US; mso-bidi-font-family: "Times New Roman"; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US; mso-themecolor: text1;">Cell
line development can either begin with an existing vector, as supplied by the
client, or vector design and construction (gene synthesis) can be performed.</span><span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US; mso-themecolor: text1;"> </span><span style="color: black; font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 115%; mso-ansi-language: EN-US; mso-bidi-font-family: "Times New Roman"; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US; mso-themecolor: text1;">Through our collaborative partnerships, Goodwin
Biotechnology can take your gene sequence or cDNA for your recombinant protein,
antibody, or hybridoma and engineer a highly productive, stable cell line in
CHO, BHK, NS0, HEK-293, SP2/0 cells or proprietary third-party systems (GS,
ACE, UCOE, PER.C6®, etc.).</span></span></span><br />
<br />
<br />
<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%; mso-themecolor: text1;">After transfection
of the cells, the other two important processes in <b style="mso-bidi-font-weight: normal;">cell line development</b> are screening amplification and sub cloning. The
cell lines will then be developed in serum-free and chemically defined suspension
conditions. The client can also opt for a stable pool of transfectants to be
generated during cell line development process. </span><br />
<span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10pt; line-height: 115%;"> </span><br />
<br />
<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 170%; mso-themecolor: text1;">The goal for this process is to generate 3 to
5 high-producing candidate clones </span><span style="color: black; font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-themecolor: text1;">and ten (10) liquid nitrogenes vials of each of three (3)
to five (5) clones will be created.</span><span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 170%; mso-themecolor: text1;">. </span><span style="color: black; font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-fareast-font-family: "Times New Roman"; mso-themecolor: text1;">The stability of the three (3) to five (5)
candidate cell lines will be evaluated in shake flask culture for up to fifty
(50) generations, for example. Cell growth kinetics and productivity will be
evaluated at regular intervals, e.g., every five (5) generations. Together with
the client, Goodwin Biotechnology will evaluate the data and choose the best
performing clone for creation of the Research Cell Bank (RCB).</span><br />
<br />
<div class="MsoNormal" style="line-height: 170%; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: 0in; margin-right: 0in; margin-top: 2.25pt;">
<span style="color: black; font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-fareast-font-family: "Times New Roman"; mso-themecolor: text1;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US;">Once
the RCB is selected, it is going to be tested for mycloplasma, sterility and adventitious
viruses, </span><span style="font-family: "Trebuchet MS","sans-serif"; font-size: 10pt; line-height: 115%;">and then shipped to Goodwin Biotechnology for
process development work and creation of a GMP Master Cell Bank </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US;">Once this is done, the reliable biotechnology
scientists at Goodwin Biotechnology <span style="mso-spacerun: yes;"> </span>will
give you a detailed report of the cell development process.</span></span></div>
<div class="MsoNormal" style="line-height: 170%; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: 0in; margin-right: 0in; margin-top: 2.25pt;">
<br /></div>
<span style="color: black; font-family: "Trebuchet MS","sans-serif"; font-size: 10.0pt; line-height: 170%; mso-fareast-font-family: "Times New Roman"; mso-themecolor: text1;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US;">The
<a href="http://www.goodwinbio.com/cell-line-development.html"><b style="mso-bidi-font-weight: normal;">cell line development</b></a> process should
be tailored to suit customers wishes. You need to find a company like Goodwin
Biotechnology that is experienced and very flexible in terms of designing cell
line development programs. Look for a company with qualified biotechnologists
with many years of experience in the industry and a validated cGMP
manufacturing facility. </span></span></span>Anonymoushttp://www.blogger.com/profile/09780487138329762497noreply@blogger.com0tag:blogger.com,1999:blog-694380603275308255.post-12830914386566668982014-05-02T09:32:00.001-07:002014-05-02T09:33:25.401-07:00Goodwin Biotechnology offers full range of cell culture services<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi1OQ1RXOfQ0Q-LujtXco9Yonp_XxJI96T1gRtx37VKLIpZIskdPB7DGKUNshqMPatmD-ohBhuWmnXKSWahu3oFhMlX1HwPyNQ-OvJUT4NivGslE59RDxlZjc__uO8N7WTr8w4388DhgtM/s1600/cell+culture.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi1OQ1RXOfQ0Q-LujtXco9Yonp_XxJI96T1gRtx37VKLIpZIskdPB7DGKUNshqMPatmD-ohBhuWmnXKSWahu3oFhMlX1HwPyNQ-OvJUT4NivGslE59RDxlZjc__uO8N7WTr8w4388DhgtM/s1600/cell+culture.jpg" /></a></div>
<div class="MsoNormal" style="background-color: white; color: #222222; font-family: arial, sans-serif; font-size: 12.800000190734863px;">
<span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">Goodwin Biotechnology offers a full range of mammalian<a href="http://www.goodwinbio.com/cell-culture.html"><b> cell culture services </b></a>ranging from the creation of up and downstream processes sufficient for the manufacturing of proof of concept, toxicology product material and processes for licensed manufacturing.<br /><br />We work with most cell lines used for manufacturing, including CHO, NS/0, BHK, 293 as well as murine hybridomas, and all selection systems used with these lines. We also work with several different selection systems such as dhfr - /methotrexate CHO, mycophenolic acid/xanthine, and G418 systems. Our experience includes surface dependent as well as suspension culture types.</span><br />
<span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;"></span><br />
<a name='more'></a><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;"><br /><br />Our clients are global and include biotech startup firms, research institutes, universities, multinational biotechnology and pharmaceutical companies, and government institutes with projects from translational medicine to producing materials for clinical trials.<u></u><u></u></span></div>
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<span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">Goodwin Biotechnology will develop a robust and reproducible cell culture process for the production of complex therapeutic protein drug candidates. Goodwin Biotechnology has experience with a number of cell cultivation technologies including stationary culture disposable flasks, spinners, WAVE disposable and stirred tank bioreactors. Goodwin Biotechnology offers cell culture production services for non-bioreactor projects.<u></u><u></u></span></div>
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<div class="MsoNormal" style="background-color: white; color: #222222; font-family: arial, sans-serif; font-size: 12.800000190734863px; margin-bottom: 0.0001pt; margin-left: 0in; margin-right: 0in;">
<u></u><span style="font-family: Symbol; font-size: 10pt;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><u></u><b><i><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">Media selection and development (both animal component and animal-free components)</span></i></b><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">... Goodwin Biotechnology offers medium evaluation and adaptation to commercial serum free formulations for your cell line. Our goal is to increase your line's productivity, growth performance, and/or compliance level.<u></u><u></u></span></div>
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<u></u><span style="font-family: Symbol; font-size: 10pt;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><u></u><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;"><u></u> <u></u></span></div>
<div class="MsoNormal" style="background-color: white; color: #222222; font-family: arial, sans-serif; font-size: 12.800000190734863px; margin-bottom: 0.0001pt; margin-left: 0in; margin-right: 0in;">
<u></u><span style="font-family: Symbol; font-size: 10pt;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><u></u><b><i><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">Development and optimization of robust and scalable processes</span></i></b><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">... Goodwin Biotechnology offers three different types of bioreactor systems for production and process development services for each. We work with clients to determine the optimum bioreactor type to use for their project based on their cell expression system and product quantities needed.<u></u><u></u></span></div>
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<u></u><span style="font-family: Symbol; font-size: 10pt;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><u></u><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;"><u></u> <u></u></span></div>
<div class="MsoNormal" style="background-color: white; color: #222222; font-family: arial, sans-serif; font-size: 12.800000190734863px; margin-bottom: 0.0001pt; margin-left: 0in; margin-right: 0in;">
<u></u><span style="font-family: Symbol; font-size: 10pt;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><u></u><b><i><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">Stirred tank batch or fed-batch bioreactor</span></i></b><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">... Stirred tank bioreactors up to 500L are available. With the possibility of achieving yields up to three grams per liter, our bioreactors could produce up to 1,500 grams per every 8 to 10 day run.<u></u><u></u></span></div>
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<u></u><span style="font-family: Symbol; font-size: 10pt;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><u></u><b><i><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">Fibracell disk immobilized bed perfusion bioreactors</span></i></b><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">...<br />Bioreactors with cartridge surface areas ranging from 2.1 to 25.2m² are available. The larger of these bioreactors can produce in excess of 150 grams during a six-week production run.<u></u><u></u></span></div>
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<u></u><span style="font-family: Symbol; font-size: 10pt;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><u></u><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;"><u></u> <u></u></span></div>
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<u></u><span style="font-family: Symbol; font-size: 10pt;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><u></u><b><i><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">Hollow fiber</span></i></b><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;"> </span><b><i><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">6 X 5L Sartorius Bioreactors</span></i></b><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">... Goodwin Biotechnology has available small bioreactor systems of each type for the development of specific run parameters and scaling data for the larger production bioreactors. These small systems are also available for the production of non-GMP material for testing and toxicology studies.<u></u><u></u></span></div>
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<span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">Goodwin Biotechnology manufactures cGMP material for clients using:<u></u><u></u></span></div>
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<u></u><span style="font-family: Symbol; font-size: 10pt;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><u></u><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">Dakota stirred tanks, 200L and 500L.<u></u><u></u></span></div>
<div style="background-color: white; color: #222222; font-family: arial, sans-serif; font-size: 12.800000190734863px; margin-bottom: 0.0001pt; margin-left: 0.25in; margin-right: 0in;">
<u></u><span style="font-family: Symbol; font-size: 10pt;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><u></u><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">50L disposable WAVE bioreactor<u></u><u></u></span></div>
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<u></u><span style="font-family: Symbol; font-size: 10pt;">·<span style="font-family: 'Times New Roman'; font-size: 7pt;"> </span></span><u></u><span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;"><u></u> <u></u></span></div>
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<span style="font-family: 'Trebuchet MS', sans-serif; font-size: 10pt;">The scale of bioreactor selected depends on the productivity of the cell line and the requirement for GMP material. Once the GMP material is produced, Goodwin Biotechnology performs in-process and release testing as well as QA review of the GMP manufacturing documentation. In addition, Goodwin Biotechnology offers stability studies, viral clearance studies, creation of a reference standard, etc. to meet regulatory compliance needs.Please<a href="http://www.goodwinbio.com/contact-us.html"><b> contact us</b></a>..</span></div>
Anonymoushttp://www.blogger.com/profile/09780487138329762497noreply@blogger.com0tag:blogger.com,1999:blog-694380603275308255.post-28435392934431676152014-03-25T09:12:00.002-07:002014-04-14T08:43:45.936-07:00Our Cell Line Development Process<!--[if gte mso 9]><xml>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiV7zHE0MuiDaZvNQAjaCjgPUWPYaD1OK0k1alrRIvjmF9b4RRFrjG5_FddkPJNNcfLXMvVtYcCqyRgE93Yu3Wy8Gx6GJfmL-bXX6oO4FMqmlUaY32k0X2gzl1IVxramzOlYMYsC0iMpy8/s1600/cell+culture+1.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiV7zHE0MuiDaZvNQAjaCjgPUWPYaD1OK0k1alrRIvjmF9b4RRFrjG5_FddkPJNNcfLXMvVtYcCqyRgE93Yu3Wy8Gx6GJfmL-bXX6oO4FMqmlUaY32k0X2gzl1IVxramzOlYMYsC0iMpy8/s1600/cell+culture+1.png" height="196" width="200" /></a></div>
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<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">Goodwin Biotechnology offers a Single Source Solution™ that starts with <a href="http://www.goodwinbio.com/cell-culture.html">cellline development </a>and extends through Process Development and cGMP
manufacturing. </span></div>
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<br /></div>
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<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">We have collaborative partners for molecular biology and cell line
development activities with whom we work to develop your cell line. Working
with our partners, we can develop cell lines from cDNA or gene sequences that
you provide for antibodies, hybridomas, or recombination proteins and to
engineer highly productive and stable cell lines in HEK-293, BHK, CHO, NS0,
SP2/0 cells or proprietary third-party systems like PER.C6®, ACE, GS, and UCOE. </span></div>
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<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";"></span></div>
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<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">Our partners offer their own proprietary vectors to develop cell lines
that can routinely produce up to 4g/L in CHO cell lines. If you have an
existing vector, we can start the cell line development from that. If you do
not, we will do gene synthesis where we do vector design and construction.</span></div>
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<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">We adopt a risk-based, Quality by Design (QbD) approach for all projects,
and specifically Cell Line Development. Before we start a project, we created a
cell line development project plan (Design Input Plan). Our clients review the
plan and we only start on the project after it is approved. </span></div>
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<br /></div>
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<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">Once transfection of the cell has been done, screening amplification and
subcloning will be performed, which is then followed by the adaptation of cell
lines to suspension culture in media that is serum-free and chemically-defined.
If you so desire, we will have a stable pool of transfectants generated and
characterized for you before we generate a high-producing single stable clone. </span></div>
<div class="MsoNormal" style="background: white; line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<br /></div>
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<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">We identify between 3 and 5 high-producing single stable clones and we
will create 10 liquid nitrogen vials of each of the clones. There is a shake
flask stage of the cell line development process where you can get a small
sample of the harvest and purify it for initial protein structural
characterization (quaternary, tertiary, secondary, or primary). You can also do
binding characteristics through such methods as binding kinetics, mass
spectrometry, amino acid analysis, glycosylation, and potency. This, coupled
with productivity and generational stability data, helps in the selection of
the best cell line for your Research Cell Bank (RCB). </span></div>
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<br /></div>
<div class="MsoNormal" style="background: white; line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">Our team also performs generational stability studies during the cell
line development<b> </b>process. We do this for up to 50 generations. We
evaluate such things as cell growth productivity and cell growth kinetics for
every five generations. We will produce up to 40 vials of the RCB and we will have
it tested for such things as adventitious viruses, mycoplasma, and sterility. We
will develop a final cell line development report which you get to review and
approve before we ship the product to you.</span></div>
<div class="MsoNormal" style="background: white; line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<br /></div>
<div class="MsoNormal" style="background: white; line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">The final product is then ready for process development work and for GMP
MCB creation. Our Process Development team is led by Dr. Legmann who has over
10 years of experience in the production and characterization of clones to
fully active mammalian and bacterial recombinant protein expression products.
She and her team have vast experience in mammalian cell culture bioreactor
optimization which makes it possible for us </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">to </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">develop a robust and reproducible cell culture
process for the production of complex therapeutic protein drug candidates</span><span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">. </span></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; line-height: 115%;">At Goodwin Biotechnology we also provide expert
Regulatory support to our clients to assist them in quickly and effectively
moving their drug candidates through the regulatory application and review
process. Goodwin Biotechnology provides full regulatory support services for
projects beginning with process development initiatives in support of
toxicology study materials through the preparation of Chemistry, Manufacturing
& Controls (CMC) information for IND filings and amendments. Our staff
provides regulatory assistance in all aspects of client projects including
meeting with regulatory agencies to discuss manufacturing and testing issues.
Our staff is knowledgeable in US, Canadian, and European requirements, as well
as guidelines for products produced using novel platforms. Please <a href="http://www.goodwinbio.com/contact-us.html">contact us</a>…</span></div>
Anonymoushttp://www.blogger.com/profile/09780487138329762497noreply@blogger.com0tag:blogger.com,1999:blog-694380603275308255.post-52938313299927095912014-03-10T12:20:00.005-07:002014-03-10T12:20:59.497-07:00Comprehensive Bioconjugation Solutions <!--[if gte mso 9]><xml>
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<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhvcyAf69L3__EELumLN7ZYe-5CUFH4xQhOf9307OHuBTV4YvuMYt47ccTkx5zTAkabvbOfKZ_JxUSTR9WgUxM5fR9ezhzJfV9chAu3C5FdRjMqWeumKC1FlscmShA_z_vb_XtbNALJgSI/s1600/bioconjugation.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhvcyAf69L3__EELumLN7ZYe-5CUFH4xQhOf9307OHuBTV4YvuMYt47ccTkx5zTAkabvbOfKZ_JxUSTR9WgUxM5fR9ezhzJfV9chAu3C5FdRjMqWeumKC1FlscmShA_z_vb_XtbNALJgSI/s1600/bioconjugation.jpg" /></a></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-layout-grid-align: none; text-autospace: none;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">There have been advances in the
field of biologics that enable scientists to synthetically modify recombinant
proteins and monoclonal antibodies and use them in therapeutics, diagnostics
and other fields. Thanks to <a href="http://www.goodwinbio.com/bioconjugation.html"><b style="mso-bidi-font-weight: normal;">bioconjugation</b></a>,
these biomolecules can be used to reveal enzyme function, to track cellular
events, to determine protein biodistribution, to image specific biomarkers, and
to deliver drugs to specific cells. </span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-layout-grid-align: none; text-autospace: none;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;"></span></div>
<a name='more'></a><br />
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-layout-grid-align: none; text-autospace: none;">
<br /></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-layout-grid-align: none; text-autospace: none;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">At Goodwin Biotechnology, we
offer a unique and unrivaled expertise in the manufacture of multi-gram protein
bioconjugates like antibody drug conjugates (ADCs). We will develop at the
earliest stages a scalable, GMP-compliant, economical and efficient process using
a risk based Quality by Design (QbD) approach that is designed to manufacture
your ADC product in an expedient manner and meet all appropriate quality
requirements relative to safety, purity, identity, potency, and immunogenicity.
</span></div>
<div class="MsoNormal" style="background: white; line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<br /></div>
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<span style="color: #222222; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">For well over a
decade, we have specialized in the conjugation of monoclonal antibodies and
recombinant proteins to make ADCs as well as radioimmunoconjugates. We are
known for the chemical <span style="mso-bidi-font-weight: normal;">bioconjugation</span>
of these products using bifunctional ligands, drug toxins like plant
protein toxins and cancer drugs, metal chelates for use in
radio-isotope labeling, chelating agents that are used in radio isotopes
labeling for therapeutic and diagnostic purposes, and adjuvants like
Aluminum Hydroxide-Antibody conjugate.</span></div>
<div class="MsoNormal" style="background: white; line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<br /></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-layout-grid-align: none; text-autospace: none;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Other conjugations we do are
conjugations using cleavable and non-cleavable linkers, Genomic DNA to antibody,
protein-to-protein conjugates, and two antibodies (fragments and full length).
We do protein biotinylation for use with avidin- or streptavidin-based reagents
and we develop key properties of therapeutic proteins to optimize in-vivo and
in-vitro performance. Our team also has expertise in protein modification
through chemical conjugation or enzyme digestion.</span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-layout-grid-align: none; text-autospace: none;">
<br /></div>
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<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">We understand the importance of
such factors as incorporation levels, isotope stability and uptake, and active
site masking in the manufacture of bioconjugates and we take extra care to
ensure you get the highest quality product. </span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-layout-grid-align: none; text-autospace: none;">
<br /></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-layout-grid-align: none; text-autospace: none;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">We also understand that common <span style="mso-bidi-font-weight: normal;">bioconjugation</span> reactions like the lysine
amino acid residue coupling, cysteine residue coupling, N- and C- terminus
modification, tyrosine residue coupling, and tryptophan residue coupling often
lack efficiency and chemoselectivity given that they depend on native amino
acid residue presence (which are usually readily available and hinder selectivity).
</span></div>
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<br /></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-layout-grid-align: none; text-autospace: none;">
<span style="color: #222222; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">Our team has the necessary training and experience for the job.
We have a state-of-the-art manufacturing plant and we manufacture bioconjugates
at GMP-compliant manufacturing scales. We have a number of patents pending. </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Bioconjugates synthesis
has a lot of challenges that range from the simple, nonspecific use of
fluorescent dye markers to the complex, highly cytotoxic antibody drug
conjugates design. </span></div>
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<div class="MsoNormal" style="background: white; line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Goodwin
Biotechnology can work with cytotoxic payloads up to Safebridge Level 3 within
our own facilities (e.g., doxorubicin or methotrexate); however, for ADCs
utilizing highly potent cytotoxic payloads (e.g., maytansine, auristatin, DM4,
or tubulysin) requiring a Safebridge level 4 / Merck level 5 facility, Goodwin
has collaborated with Coldstream Laboratories where we seamlessly execute all
conjugation processes within Coldstream’s high-containment facilities, from
proof-of-concept through late-stage clinical trials and large-scale cGMP
manufacturing or commercial products.</span></div>
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<br /></div>
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<span style="color: #222222; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">We have customized
solutions since we understand that our clients have unique needs. We will
involve you in the entire<b style="mso-bidi-font-weight: normal;"> <a href="http://www.goodwinbio.com/bioconjugation.html">bioconjugation</a></b>
process and you will have the final say on major decisions. We offer a Single
Source Solution™ or a one-stop-shop when it comes to biotechnology and w</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">e invite you to
try our comprehensive solutions.</span><span style="mso-bidi-font-size: 12.0pt;">
</span></div>
Anonymoushttp://www.blogger.com/profile/09780487138329762497noreply@blogger.com0tag:blogger.com,1999:blog-694380603275308255.post-24595251432199546332014-03-10T12:13:00.001-07:002014-03-10T12:13:54.754-07:00An Overview of Our Cell Culture Manufacturing Service<!--[if gte mso 9]><xml>
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<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiSZeiei6fRSrpuYP9KSupvq_t1mmPj4n9j1OCYbAq99h5bvCkdRmqAoh6v89d7g8AQVEnOH_BW1ySMLiyGQvJHHk02x0zPcXCwV6gs8R1OHbbuw1B6hRgA7upjurcUXVa9a-5EJmVvn2g/s1600/cell+culture.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiSZeiei6fRSrpuYP9KSupvq_t1mmPj4n9j1OCYbAq99h5bvCkdRmqAoh6v89d7g8AQVEnOH_BW1ySMLiyGQvJHHk02x0zPcXCwV6gs8R1OHbbuw1B6hRgA7upjurcUXVa9a-5EJmVvn2g/s1600/cell+culture.jpg" /></a></div>
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<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">Goodwin Biotechnology offers a full range of mammalian cell culture
services ranging from cell line development, with our partners, through the
creation of up and downstream processes sufficient for the manufacturing of
proof of concept, toxicology product material and processes for licensed cGMP manufacturing.</span></div>
<div class="MsoNormal" style="background: white; line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";"></span></div>
<a name='more'></a><br />
<div class="MsoNormal" style="background: white; line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";"><br />
We work with most cell lines used for manufacturing, including CHO, NS/0, BHK,
293 as well as murine hybridomas, and all selection systems used with these
lines. We also work with several different selection systems such as dhfr -
/methotrexate CHO, mycophenolic acid/xanthine, and G418 systems. Our experience
includes surface dependent as well as suspension culture types.</span></div>
<div class="MsoNormal" style="background: white; line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<br /></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<a href="http://www.goodwinbio.com/cell-culture.html"><b><span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">Cell culture manufacturing</span></b></a><span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";"> operations at Goodwin
Biotechnology are managed by SooYoung S. Lee, PhD, Chief Operating Officer, who
has several decades of experience in the biotechnology industry. </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">After earning
his PhD in Biochemical Engineering at Cornell University, he held several<span style="mso-spacerun: yes;"> </span>leadership positions at leading
biopharmaceutical companies and CMO’s such as SAIC – Frederick, Schering-Plough
Research Institute, Wyeth – Lederle Vaccines, AppTec, Neose Technologies and
Genencor. He also has extensive experience in international biotechnology
operations, having established and served as the Director of the
Biopharmaceutical Manufacturing Technology Center (BMTC) in Singapore, and as a
Senior Member, he helped establish the International Vaccine Institute (IVI) in
Seoul, Korea.<span style="mso-spacerun: yes;"> </span>SooYoung’s </span><span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">team is equally
competent. It has vast combined experience in all aspects of cell culture
expression systems. As importantly, the team is highly trained in compliance
programs and quality systems.</span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<br /></div>
<div class="MsoNormal" style="background: white; line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">Our cell culture manufacturing clients come from all over the
world. They range from universities to research institutes and from biotech
startup firms to pharmaceutical companies. Our clients are usually looking for
material for everything from pre-clinical and tox studies to late-stage
clinical trials. </span></div>
<div class="MsoNormal" style="background: white; line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<br /></div>
<div class="MsoNormal" style="background: white; line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">We understand the need </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">for </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">robust
and reproducible cell culture process for the production of complex therapeutic
protein drug candidates,</span><span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";"> and as such, our cell culture manufacturing process is of the
highest quality, no matter the complexity of the product being produced. We
employ different cell cultivation technologies which range from stationary
culture disposable flasks, spinners, WAVE disposable and stirred tank
bioreactors. Our variety of bioreactor systems include stirred tank batch/fed-batch
bioreactors with capacities of up to 500 liters and with yields of up to 3
grams per liter, Fibracell disk immobilized bed perfusion bioreactors with
cartridge surface areas from 2.1m² to 25.2m² and with yields of over 150 grams over
6-week production runs, and 6 X 5L Sartorius </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">Bioreactors for the </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">development of specific run
parameters and scaling data for the larger production bioreactors. These small
systems are also available </span><span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">for those who want non-GMP material for toxicology
studies and testing. </span></div>
<div class="MsoNormal" style="background: white; line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<br /></div>
<div class="MsoNormal" style="background: white; line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">An important part of our manufacturing process is media selection &
development (for both animal-free and animal components). We do the media selection
with the optimization of your line’s productivity, compliance level, and growth
performance in mind. </span></div>
<div class="MsoNormal" style="background: white; line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<br /></div>
<div class="MsoNormal" style="background: white; line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">We also offer support services such as the outsourcing of testing to qualified
independent safety testing laboratories, Assay development and characterization,
quality control, and quality assurance.</span></div>
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<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">Quality is very important to us and as such</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">, </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Quality is the intrinsic focus of all management
practices that make up these systems. These </span><span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">cell culture manufacturing</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;"> practices include the following
elements: proper planning, performance of appropriate tasks, timely assessment,
and continuous improvement of established processes. By addressing these
elements in the research, development, operations, and support activities,
defined goals are met and both the Goodwin Biotechnology and the client
requirements are satisfied. All work is performed with dedication to excellence
and with an objective of dynamic and continuous improvement.</span></div>
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<span style="color: black; font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-bidi-font-weight: bold; mso-fareast-font-family: "Times New Roman";">We understand that our clients are looking for comprehensive solutions
and as such, we do more than<a href="http://www.goodwinbio.com/cell-culture.html"> <b>cell culture manufacturing</b></a>. Other related
services are bioconjugation (including highly cytotoxic antibody drug
conjugates [ADCs]), avian and tobacco plant transgenics, as well as biosimilars
and biobetter development. </span></div>
Anonymoushttp://www.blogger.com/profile/09780487138329762497noreply@blogger.com0tag:blogger.com,1999:blog-694380603275308255.post-78879241162403106242014-02-28T07:40:00.001-08:002014-02-28T07:40:48.926-08:00Cell Culture, Bioreactors and Your Opinion! So...quick question! <br /><br />Are you using a single use or stainless steel bioreactor?<br />Anonymoushttp://www.blogger.com/profile/09780487138329762497noreply@blogger.com1tag:blogger.com,1999:blog-694380603275308255.post-12628461954359076362014-02-28T07:34:00.000-08:002014-02-28T07:34:24.490-08:00A Perspective on Goodwin Biotechnology In my five years as a member of the Goodwin family, two as a manufacturing scientist and 3 as Downstream Operations Manager, the most important thing over the years has been the “can do” attitude of the entire team. From QA, QC, Process Development to Manufacturing, we continually step up to do what’s needed to complete a client’s project. Goodwin is a great place to start out a career as we continually reinforce good manufacturing process from start to finish and it shows! Anonymoushttp://www.blogger.com/profile/09780487138329762497noreply@blogger.com0