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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.

During the manufacturing process, therapeutic antibodies are exposed to a range of hydrodynamic forces and material contact surfaces that can potentially impact protein stability and propensity for aggregation. These forces can vary as fluid flow rates and component design elements scale alongside batch size.

GORE Protein Capture Devices with Protein A are intended for the affinity purification of monoclonal antibodies and other proteins containing an Fc region derived from clarified cell culture harvests in process development to initial GMP clinical applications.

Discover how rapid cycle Protein A membrane chromatography can boost your antibody purification process productivity by trying the new GORE® Productivity Calculator.

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This application note provides data demonstrating high productivity, extended cycling durability performance of membrane-based GORE Protein Capture Devices with Protein A across two rapid Clean-in-Place methods bracketing caustic contact time and concentration. These data were then combined with results from a manufacturing-scale demonstration to extrapolate protein capture capabilities at a 2000 L batch bioreactor size across CIP methods.

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.

This application note demonstrates the scalability across multiple GORE Protein Capture Device sizes through dynamic binding capacity, CHO cell harvest, and purification experiments as demonstrated with a partially purified monoclonal antibody.

The 9.0mL Device (PROA103) GORE Protein Capture Device provides performance advantages over traditional agarose resin columns in late stage discovery, pre-clinical and early clinical applications.

General handling, antibody purification protocol and troubleshooting guide for PROA103.

General handling, antibody purification protocol, troubleshooting, and ordering information.