Purification Process Development
GBI'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 monoclonal antibodies (including IgG, IgA and IgM subclasses) and recombinant proteins from mammalian, as well as 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 the regulatory requirements for product's development status.
GBI 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.
As the product proceeds through its clinical evaluation, GBI 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, GBI will have developed a process that can be transferred for commercial manufacturing and ready for qualification runs with a minimum of problems.
Bioconjugation And Protein Modification
Whether the conjugate is a drug toxin (small molecule cancer drugs, plant protein toxins), chelating agents for radio isotopes labeling (diagnostics and therapeutics), adjuvants such as Aluminum Hydroxide-Antibody conjugate, or other antibodies, GBI has the ability to develop and perform them at GMP compliant 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.
GBI has both the expertise and experience in protein modification utilizing either chemical conjugation or enzymatic digestion. 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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Dr. Muctarr Sesayís perspective on the field of Bioconjugation.