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Validation Guide: GORE Protein Capture Device 58mL, 116 mL, and 232 mL

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), and 232 mL (PROA203).

This document is available upon request.

English (U.S.)

Operating Instructions: GORE Protein Capture Device for 58mL, 116 mL, and 232 mL

Chromatography

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

English (U.S.)

GORE Protein Capture Device 58mL

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.)

Image of app note

Chromatography

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.

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 GORE® Protein Capture Devices Validation Guide

Chromatography

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.

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.)

Image of Application Note for GORE® Protein Capture Device Used in Manual LC Methods

Chromatography

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.

English (U.S.)

Image of Application Note for GORE® Protein Capture Device Used in Series

Chromatography

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.

English (U.S.)

Application Note: Sodium Hydroxide (NaOH) Exposure Conditions for Successful Operation of GORE<sup>®</sup> Protein Capture Devices with Protein A for Drug Discovery Applications

Chromatography

This application note provides data to support sodium hydroxide (NaOH) exposure limits for the 1.0mL and 3.5mL GORE Protein Capture Devices (PROA101 and PROA102). The cycling protocol utilizing 0.5 molar (M) NaOH supports 50 purification cycles with minimal impact to purification yield, device capacity, or assessed purity.

English (U.S.)