Membrane, Resin, And Impact To Product: Overcoming Barriers To Adopting Membrane Technology By Demonstrating Protein A Affinity Capture Step Product Quality And Process Characteristic Similarity

In this study, a set of proposed criteria was utilized to demonstrate comparability in product quality and chromatographic process characteristics between a Protein A affinity capture membrane and a packed-bed resin reference. The product quality attributes and process impurities from a purified IgG1 monoclonal antibody cell culture harvest were similar between the Protein A resin and membrane affinity stationary phases. The membrane exhibited significantly higher chromatographic productivity. Compared to previously published manufacturing-scale data, these laboratory-scale results indicate that resin and membrane Protein A media can be used interchangeably. Furthermore, they suggest that both media types can be validated concurrently across laboratory scale, process development, clinical bioprocessing, and manufacturing scale bioprocessing.