Frost
& Sullivan Presents
Goodwin
Biotechnology with the Global Customer Value Leadership Award for Mammalian Biologics
Contract Manufacturing
Goodwin Biotechnology pioneered best-in-class practices for the
development of complex Biopharmaceuticals and Antibody Drug Conjugates (ADCs)
LONDON — September 2,
2014 — Based on its recent analysis of
the mammalian contract manufacturing services market, Frost & Sullivan recognises Goodwin
Biotechnology with the 2014 Global
Frost & Sullivan 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.
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.
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.
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 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.
“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.”
“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.”
“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.”
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.
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.
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.
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 and measure performance through in-depth interviews,
analysis and extensive secondary research to identify best practices in the
industry.
About Goodwin Biotechnology
Goodwin
Biotechnology 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 http://www.GoodwinBio.com.
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