Robustness of virus removal by Protein A chromatography is independent of media lifetime and mechanism of degradation

BIOT 298

Scott Lute, lute@cber.fda.gov1, Lenore Norling, norling.lenore@gene.com2, Michael Hanson, mhanson1@umbc.edu3, Qi Chen4, and Kurt Brorson, kurt.brorson@fda.hhs.gov1. (1) Division of Monoclonal Antibodies, Center for Drug Evaluation and Research, Food and Drug Administration, 29 Lincoln Dr, Bethesda, MD 20892, (2) Late Stage Purification, Genentech, Inc, 1 DNA Way, South San Francisco, CA 94080, (3) Chem Engineering, University of Maryland, Baltimore County/CDER, FDA, 29 Lincoln Dr, Bldg 29B, Rm 5E16, Bethesda, MD 20892, (4) Late Stage Purification, Genentech, One DNA Way, South San Francisco, CA 94080
We used commercial process intermediates in scaled down studies with three media (Protein A immobilized ProSep A, Poros A50, Protein A ceramic Hyper DF) to show that endogenous retrovirus particle clearance is not impacted by extensive cycling under forced degradation conditions. We also looked at virus carry over by spiking the feedstocks with a bacteriophage PR772 for the ProsepA 0.1M H3PO4 and 100mM NaOH experiments. The stability of the chromatographic resins to clear virus after multiple cycling resins was also tested for clearance of three other viruses (SV40, X-MuLV, and MMV). Thus, clearance of all of these viruses by protein A chromatography appears to be extremely robust with respect to resin age; virus carry over can be minimized with good resin packing quality.
 

Poster Session
5:30 PM-7:30 PM, Wednesday, 13 September 2006 Moscone Center -- Hall D, Poster

Sci-Mix
8:00 PM-10:00 PM, Monday, 11 September 2006 Moscone Center -- Hall D, Sci-Mix

Division of Biochemical Technology

The 232nd ACS National Meeting, San Francisco, CA, September 10-14, 2006