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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.

Protein Capture Device Protein A reverse flow cycles

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.

LEP Testing: Because All Liquids Are Not the Same

This document explains why Gore performs both WEP and LEP tests to understand the physical properties of formulations in order to engineer the appropriate venting solution.

GORE STA-PURE Flexible Freeze Container Technical Guide Image

Describes the freeze profile of the GORE® STA-PURE® Flexible Freeze Container including the freeze methodology and the impact of the carrier on freeze performance.

This document is available upon request.

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.

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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).

Protein Capture Device Protein A reverse flow cycles

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.

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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.