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Pharmaceutical & Biopharmaceutical

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.

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.)

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.)

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.)

Protein Capture Device Protein A reverse flow cycles

Pharmaceutical & Biopharmaceutical

This application note demonstrates utilizing a rapid CIP and optimizing the loading and non-loading residence times during cycling to achieve increased productivity on a Gore Protein Capture Device. The method is easily transferred from lab scale to pilot scale sizes as demonstrated using both PROA101 (1mL) and PROA201 (58 mL) Gore Protein Capture Devices.

English (U.S.)

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Pharmaceutical & Biopharmaceutical

This technical note provides evidence based through ELISA assays that the GORE® Protein Capture Device did not have carryover after consecutive cycling of two different cell culture harvests when separated by a 15-minute sanitization cycle using 0.1 M NaOH.

English (U.S.)

Application Note: Aragen's A Platform to Rapidly Purify and Formulate Immunoglobulins from Mammalian Expression Systems

Chromatography

Recently introduced technologies such as Protein A membrane devices and tangential flow filtration (TFF) systems capable of handling ultrafiltration and diafiltration of samples as low as 5 mL have significantly decreased the turnaround time.

This document is available upon request.

English (U.S.)

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Chromatography

Boehringer-Ingelheim evaluated GORE Protein Capture Devices with Protein A vs. a traditional agarose bead column and found that, together with high titers, the GORE column can reduce overall process time and may help increase yields in monoclonal antibody purification by eliminating the need for additional downstream concentration steps.

English (U.S.)

Image of Application Note for GORE® Protein Capture Device Cleaning Protocols

Chromatography

Two cleaning protocols outlined in this application note potentially extend the lifetime of a GORE Protein Capture Device in the event that pressure elevates over the expected lifetime of the device.

English (U.S.)