(301b) High Capacity Protein a Membranes for Mab Capture:  an Alternative to Column Chromatography

Bind and elute membrane chromatography is receiving increased attention in the downstream purification of therapeutic proteins. The success of flowthrough AEX membrane chromatography and the development of next-generation high capacity materials have enabled a membrane-based affinity mAb capture step in a single-use format. In this talk, several novel Protein A hydrogel prototypes for mAb capture were tested in bind and elute mode. Different formulations of pore size and permeability were screened to find an optimal membrane with desired flow characteristics and binding capacity. A faster Protein A process with improved impurity clearance was demonstrated for 2 mAbs when compared to a traditional column process. High yield and impurity clearance is maintained over 50 cycles while operated at residence times as low as 2 second and loadings up to 30 g/L. Further, continuous operation of the developed capture step is demonstrated by integrating multiple membranes into a multi-column chromatography skid (BioSMB) to facilitate rapid membrane cycling. This integration capability into continuous downstream operation along with the improved impurity clearance and productivity demonstrates these membranes are a promising option for future downstream purification.