(217e) Multimodal Membrane Adsorbers for Clearance of Minute Virus of Mice

During purification, manufacturers of mAbs and other therapeutic proteins must demonstrate reduction of 10³ -10⁵ or more virus particles than is estimated in a single dose equivalent of the unprocessed bulk. The level of virus clearance is calculated by summing the clearance obtained from individual unit operations having different mechanisms of action (e.g. size exclusion and ion exchange). Depending on the antibody titer, estimates of the number of virus particles in a single dose equivalent could be as high as 10¹⁰-10¹⁵ retrovirus-like particles per mL. In addition, removal of adventitious virus using a model parvovirus is required. In recent years, several membrane adsorbers with high binding capacity have evolved for the removal of contaminants for the polishing steps during downstream purification of biologics. In particular, multimodal membrane adsorbers with tunable pore sizes and ligand properties have generated tremendous interest due to their many possible applications. Here the removal of Minute Virus of Mice (MVM), host cell proteins (HCPs) and DNA using multimodal membrane adsorber Puriâ„¢-MQ was studied. The membrane performance was evaluated over a range of feed and elution conditions. The effects of pH and HCP concentration on MVM clearance were investigated. Comparison with other membranes at similar conditions demonstrates that multimodal membranes are highly effective for virus clearance.