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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.

DATASHEET:  GORE Protein Capture Device for Early Clinical Applications

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.

Document image: GORE Protein Capture Device for Early Clinical Applications, 9.0mL (PROA103) - Operating Instructions

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

Image of Operating Instructions for GORE® Protein Capture Devices

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

Image of Data Sheet for GORE® Protein Capture Devices

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.

Validation Guide: GORE® Protein Capture Device 58 mL through 1 L

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), 232 mL (PROA203), 250 mL (PROA301), 500 mL (PROA302), and 1L (PROA303).

This document is available upon request.

Operating Instructions: GORE® Protein Capture Device for 58 mL through 1 L

General handling, antibody purification protocol and troubleshooting guide for 58mL (PROA201), 116 mL (PROA202), 232 mL (PROA203), 250 mL (PROA301), 500 mL (PROA302), and 1L (PROA303).

Datasheet: GORE<sup>®</sup> Protein Capture Device 58 mL through 1 L

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.

GORE PTFE Fiber Solutions Brochure

GORE® Fibers are engineered to offer exceptional performance in a range of challenging environments. With a thorough scientific understanding of fluoropolymers, Gore has developed the unique capability to modify the characteristics of a fiber to meet the specific demands of varied applications.

Data Sheet: Gore ePTFE Fiber Solutions

Gore fiber is composed of proprietary ePTFE – a uniquely designed fluoropolymer fiber – with a microporous structure and specific engineered physical qualities that transform products from the ordinary to the extraordinary.