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GORE™ protein capture whitepaper comparability affinity chromatography

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.

Protein A Membrane Devices Upstream Technology AGC Biologics

An intensified and fully single use downstream operation was demonstrated to process a monoclonal antibody cell culture harvest at a manufacturing scale.  The results of the study were combined with previously published data to show the potential for high productivity affinity capture sufficient up to 10 g/L titers at the 2000 L scale.