Monday, July 30, 2007
P20
Process Development for Recombinant Protein Production and Recovery
Stephen E. Sobacke, Sriram Srinivasan, Marc Perez, Paul Lanter, Will Miller, and Bruce Bishop. Global Biologics, Pfizer Inc., 700 Chesterfield Parkway West, Chesterfield, MO 63017-1732
The objectives of Process Development are to define, develop, scale-up, and document the best possible process technology to enable successful technology transfer and production of clinical supplies. To achieve these goals one must identify process variables for each unit operation and understand their effects on process performance criteria. This knowledge is key to defining optimum process conditions and identifying potential critical process parameters. Following these objectives, experimentation was performed to define process steps, optimize setpoints, verify operating ranges, and determine acceptable ranges. The data presented is based upon 15L scale protein production and 1L scale recovery experiments.
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See more of The Annual Meeting and Exhibition 2007 (July 29 - August 2, 2007)