726b Ultra-Scale down Approaches for the Separation of Mammalian Cell Culture Broth In a Disc-Stack Centrifuge

Ferhana Zaman, Downstream Purification, Bioprocess Research & Development, Pfizer Inc., 700 Chesterfield Parkway West,, HH211-U, Chesterfield, MO 63017 and Sa V. Ho, Global Biologics, Pfizer, 700 Chesterfield Parkway West, Chesterfield, MO 63017.

Recovery of monoclonal antibodies produced extracellularly in mammalian cell culture systems typically requires centrifugation for the removal of cells and cell debris. Due to the complex nature of the centrifugation unit operation and the shear sensitiveness of the cell material, it is often difficult to obtain predictive laboratory scale data to closely mimic the performances of large scale centrifuges. The use of ultra scale-down studies to understand and better predict the clarification performance of pilot and industrial-scale continuous centrifuges for different monoclonal antibodies will be evaluated. With small material requirements, these approaches will allow rapid optimization of operating conditions.