Monday, August 11, 2008
P76

Technology Transfer Scaleup and Process Fitting of a Recombinant E. coli Fermentation Process to Manufacturer of rApoA 1 Milano Protein Intermediate

Paul B. Lanter and Bruce F. Bishop. Global Biologics, Pfizer Corporation, 700 Chesterfield Parkway West, Chesterfield, MO 63017

rApoA 1 Milano is a protein intermediate for the reduction of cardiovascular atheroma, (plaque).  It is produced in a recombinant E. coli process designed to secrete the protein into the periplasmic space.  This poster will describe the technology transfer into the Pfizer Global Biologics group in St. Louis,Mo,  process demonstration at lab scale, and technology transfer to a Contract Manufacturer for production of rApoA 1 Milano.  In the course of technology transfer, process fitting studies demonstrated the capability to increase the volumetric titer of product 2x fold (2 - 4 g/L) while maintaining a constant specific productivity by modifying induction density.