(211c) Rapid Characterization of HCP Removal on Adsorptive Membranes Using Protein Surrogate Biomarkers

Anion exchange membrane adsorbers are used for clearance of impurities such as viruses, host cell protein (HCP), and DNA in flow-through polishing steps for manufacture of monoclonal antibody therapeutics. HCP can be very complex in nature. CHO host cell protein composition shows that the majority of HCP in general, and in Protein A eluates in particular, are acidic proteins with pI ~ 4-6 and molecular weight between 10-75 kDa. In this study, surrogate biomarkers or model proteins that are easily available, easy to quantify and have properties comparable to typical host cell proteins, are utilized for rapid characterization of anionic membranes. Choice of these model proteins allowed for a large number of experiments to be carried out at moderate costs, thus enabling study of a broad range of conditions for determining binding constants and capacity for HCP adsorption for Q membranes. The results of these studies will be presented. Use of surrogate biomarkers for rapid and reproducible scale-up of membrane adsorbers will also be discussed