Resource Library

When comparing containment systems for cold chain use, it is critical to understand all the factors that can affect performance. Although polymer bags are an excellent choice for this application, not all polymer films perform the same way, even if their specifications rate them for use at low temperatures. A full suite of application testing is necessary to determine whether a bag will hold up to all the rigors of handling and shipping at extremely cold temperatures.

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.

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

Risks in the biopharmaceutical cold chain and how GORE STA-PURE Flexible Freeze Containers utilize ePTFE to address the risk.

Growth in biologics, benefits and risks of single use bags and how GORE STA-PURE Flexible Freeze Containers can help.

Market trends to cold temperature storage, challenges this poses with traditional bottles and bags and how PTFE can help.

Growth in biologics, benefits and risks of single use bags and fluoropolymers and why not all Fluoropolymers are the same.

Market demands that are driving single use technologies, potential challenges this can cause and how PTFE can help.

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.

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.