Membrane, Resin, and Impact to Product: Overcoming Barriers to Adopting Membrane Technology

Comparability in both product quality and chromatographic process characteristics between a Protein A affinity capture membrane and a packed-bed resin reference was demonstrated using a set of proposed criteria. Product quality attributes and process impurities from a purified IgG1 monoclonal antibody cell culture harvest were comparable between Protein A resin and membrane affinity stationary phases, with the membrane demonstrating order-of-magnitude higher chromatographic productivity. When referenced to previously published manufacturing-scale data, these laboratory-scale results suggest that membrane and resin Protein A media can be used interchangeably and that they can be concurrently validated across lab scale, process development, clinical bioprocessing, and manufacturing scale bioprocessing.