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Viral Filtration of High-Titer Mab Solutions with Hollow Fiber Membranes

Bruno F. Marques1, Nihal Tugcu2, M. Ellen Dahlgren2, Sarah Parola2, and David J. Roush2. (1) Downstream Process Development, GlaxoSmithKline, 709 Swedeland Road, UE0551, King of Prussia, PA 19406, (2) BioPurification Development, Merck & Co., 126 E. Lincoln Ave., P.O. Box 2000, Rahway, NJ 07065

Viral filtration (VF) of concentrated monoclonal antibody (MAb) solutions (> 4 g/L) has the potential to improve downstream purification processes by eliminating VF feed stream dilution and by reducing filter area with a concomitant reduction in filter costs. Evaluation of hollow fiber membrane filters was performed with MAb solutions ranging in concentration from 4 to 20 g/L. The resulting flux profiles were fairly constant with values between 45-65 LMH, even when filter loading was extended to 200 L/m2. In contrast, other types of viral filter, such as PVDF disc membranes, were plugged by MAb solutions with concentration > 4 g/L well before 50 L/m2. Viral clearance data confirm the ability of high-capacity hollow fiber membranes to achieve > 3 log reduction of two different model viruses (XMuLV and MMV), independent of MAb concentration. Finally, the scale-up properties of different viral filters will be discussed in relation to a theoretical model.