The Highest Quality Process Development

Goodwin Biotechnology will develop a robust and reproducible cell culture process development 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.

·         Media selection and development (both animal component and animal-free components)... 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.

·         Development and optimization of robust and scalable processes... 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.

·         Stirred tank batch or fed-batch bioreactor... 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.

·         Fibracell disk immobilized bed perfusion bioreactors... 

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.

·         Hollow fiber

·         6 X 5L Sartorius Bioreactors... 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.

Further, 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.

Goodwin Biotechnology has a broad range of experience with the following: 

         Monoclonal Antibodies, Antibody Fragments (including IgG, IgA and IgM subclasses)

         Recombinant Proteins

         Growth Factors, Cytokines

         Hormones, Enzymes

         Antibody Conjugates

         Radio-labeled Antibodies

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.

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.

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.