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Protein A Membrane Devices Upstream Technology AGC Biologics

Chromatography

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.

English (U.S.)

Protein Capture Device Protein A reverse flow cycles

Pharmaceutical & Biopharmaceutical

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.

English (U.S.)

Protein Capture Device Protein A

Pharmaceutical & Biopharmaceutical

This application note demonstrates the capability of GORE® Protein Capture Devices with Protein A (GPCD) to increase productivity and meet critical quality attributes through 200 purification cycles with a rapid CIP method by testing a representative 1.0 mL device (part number PROA101).

English (U.S.)

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.

English (U.S.)

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

Chromatography

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

English (U.S.)

Image of Operating Instructions for GORE® Protein Capture Devices

Chromatography

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

English (U.S.)

Image of Data Sheet for GORE® Protein Capture Devices

Chromatography

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.

English (U.S.)

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

Chromatography

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.

English (U.S.)

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

Chromatography

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).

English (U.S.)

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

Chromatography

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.

English (U.S.)