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Designed for the affinity purification of monoclonal antibodies from clarified cell culture harvest (CCH) streams in process development and clinical applications. Request the Validation Guide for complete testing details for the GORE Protein Capture Device 58mL (PROA201), 116 mL (PROA202), and 232 mL (PROA203).

This document is available upon request.

General handling, antibody purification protocol and troubleshooting guide for 58mL (PROA201), 116 mL (PROA202), and 232 mL (PROA203).

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.

This evaluation demonstrates a method to improve productivity by increasing flow rates for the non-loading steps with a representative clarified CHO cell harvest with the 58mL, GORE Protein Capture Device (PROA201) and maintaining critical quality attributes including yield, purity and elution widths.

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

Designed for small-scale affinity purification of monoclonal antibodies, GORE Protein Capture Devices provide high binding capacity at short residence time with the potential for fewer process steps.

This document is available upon request.

GORE Protein Capture Devices use a unique expanded polytetrafluorethylene (ePTFE) membrane composite that provides a binding capacity advantage at high flow rates to improve the speed of purification in drug discovery applications.

The GORE Protein Capture Device with Protein A can be used as demonstrated in three different manual/semi-automated operations to rapidly purify monoclonal antibodies without an LC unit.

Two 3.5 mL GORE Protein Capture Devices can be connected in series, which doubles the column capacity by providing a 7.0 mL bed volume and allows capture of at least 200 mg of monoclonal antibody within 60 minutes.

A discussion on how new updates to quality standards encourage medical device manufacturers to expect more from their upstream component suppliers.

This document is available upon request: