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3. The development and application of a monoclonal antibody purification platform: a purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies

Author

Glynn, Judy, Hagerty, Timothy, Pabst, Timothy, Annathur, Gopinath, Thomas, Kristin, Johnson, Paul, Ramasubramanyan, Natarajan, and Mensah, Paul

Subjects
Biopharmaceutics -- Health aspects, Mathematical optimization -- Health aspects, Immunoglobulin G -- Health aspects, Monoclonal antibodies -- Health aspects, Biotechnology industry, Business, Pharmaceuticals and cosmetics industries
Abstract

The following article describes the development of a purification platform for monoclonal antibodies (MAbs) at Pfizer's Global Biologics division, including how the individual unit operations have been affected by increasing cell culture titers and subsequent changes in the impurity profile, as well as viral clearance issues. The platform was developed to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies. The success of this platform in its various stages has been demonstrated for several MAbs representing different IgG classes produced in different cell lines., [ILLUSTRATION OMITTED] Recent advances in mammalian cell culture technology have resulted in significant increases in upstream productivity, with antibody titers of >5 g/L becoming increasingly common. Such increases could change [...]

Published
2009

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