Membrane, Resin, And Impact To Product: Overcoming Barriers To Adopting Membrane Technology

By Shunsuke Shiina, Ph.D., Neha Saxena, Ph.D., and Rodrigo Gonzalez, Ph.D., AGC Biologics, Inc.; and Jeffrey Cassel, Eric Van Voorhees, and William C. Barrett, Ph.D., W.L. Gore & Associates, Inc.

A comprehensive comparison between Protein A affinity capture membrane and packed-bed resin was conducted to assess product quality and chromatographic process characteristics, using a set of proposed criteria. The results revealed that product quality attributes and process impurities in the purified IgG1 monoclonal antibody cell culture harvest were comparable across both Protein A resin and membrane affinity stationary phases. Notably, the membrane exhibited significantly higher chromatographic productivity by an order of magnitude.

When compared to previously published data from manufacturing-scale processes, these laboratory-scale findings suggest that Protein A membrane and resin media can be used interchangeably. Additionally, they can be concurrently validated at various stages, including lab scale, process development, clinical bioprocessing, and full-scale manufacturing, offering a flexible and efficient solution for the biomanufacturing industry.