Products and Services
Downstream Process Development
•Goodwin Biotechnology Brochure
GBI has a downstream process development department to assist clients to develop and refine purification processes. With an extensive background in the purification of monoclonal antibodies (including IgG, IgA and IgM subclasses) and recombinant proteins from mammalian, microbial and plant and animal transgenic systems, GBI can quickly develop a purification process for clients that will maximize yields for the target molecule, meet required purity levels, and be compliant with current regulatory requirements. GBI has successfully developed purification processes for over 50 clients. GBI can also receive an already developed process to its labs for evaluation and refinement into an optimized and compliant process.
Protein Modification and Conjugation
GBI has both the expertise and experience in protein modification utilizing either chemical conjugation or enzymatic digestion.
Conjugation of antibodies with other molecules is a specialty of GBI's development and manufacturing groups. Whether the conjugate is a drug toxin, chelating agent for radio isotopes adjuvants such as Aluminum Hydroxide-Antibody conjugate, or other antibodies. GBI has the ability to not only develop and perform small scale preparations but to assure that the processes are GMP compliant and to perform them at manufacturing scales for clinical applications. The development group fully understands the issues involved with these processes such as incorporation levels, active site masking and isotope uptake and stability. The manufacturing group has utilized these processes in the production of multi-gram lots of conjugated antibodies that have been administrated in clinical trials throughout the world. To date GBI has developed and manufactured numerous conjugated drug products.
Antibody modification through enzyme digestion is another GBI staff specialty. The production of Fab and F(ab')2 fragments and their subsequent purification can be achieved to a client's specifications. These processes are GMP compliant and scalable to multi-gram lot sizes for clinical applications.
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