Comparison of tangential flow filtration and centrifugation for monoclonal antibody harvest clarification

BIOT 262

James Schroeder1, Albert Krul2, and Frank Riske1. (1) Genzyme Purification Development, Genzyme Corporation, MA, (2) Genzyme Corp
Two candidate technologies, Tangential flow filtration, and centrifugation followed by depth filtration, were evaluated for the initial clarification of fed batch harvest containing a monoclonal antibody. The goal was to evaluate and compare the two technologies so that one of the technologies could be chosen for use at full scale. Optimal operating parameters for both systems were determined using scale-down systems. Volume end-point (Vmax) method using 0.2 and 0.45 um filters was developed to evaluate the quality of the clarified product. Product breakthrough endpoint (Pmax) testing was utilized to evaluate depth filters to be used in conjunction with centrifugation. Based on the results of these studies, and consideration of factors such as step yield, buffer usage, CIP / SIP, man power requirements, maintenance, robustness, and other economic factors, centrifugation with depth filtration was chosen for the process at scale.

Poster Session
5:30 PM-7:30 PM, Wednesday, March 31, 2004 Anaheim Convention Center -- Hall A, Poster

Division of Biochemical Technology

The 227th ACS National Meeting, Anaheim, CA, March 28-April 1, 2004