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

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.

GORE Protein Capture Device for Early Clinical Applications, 9.0mL (PROA103)

This unique membrane Device offered in 9.0 mL has a capacity of ≥ 360 mg when using 1.25 mg/mL human polyclonal hIgG in phosphate-buffered solution at 30 seconds residence time (SRT).  Request the Validation Guide for complete testing details.

This document is available upon request.

STA-PURE Pump Tubing Series PCS Validation Guide

GORE STA-PURE Pump Tubing Series PCS is a durable, resilient tubing product used in peristaltic pumps and is suitable for pharmaceutical and biopharmaceutical manufacturing. The product delivers consistent flow rate and low incidence of rupture, even at operating pressures up to 100 pounds per square inch gauge (psig), thus enabling the pump to work reliably under challenging conditions.

This document is available upon request.

Image of STA-PURE Pump Tubing Series PFL Validation Guide

GORE® STA-PURE® Pump Tubing Series PFL is a durable, resilient tubing product used in peristaltic pumps and is suitable for pharmaceutical and biopharmaceutical manufacturing. The product delivers consistent flow rate and low incidence of rupture, even with aggressive chemicals, at operating pressures up to 60 pounds per square inch gauge (psig).

This document is available upon request.

Validation Guide: GORE LYOGUARD Freeze-Drying Trays

A comprehensive guide for validating these trays for use in your application. This document is available upon request.

Image of GORE® Protein Capture Devices Validation Guide

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.

Thumbnail image of validation guide document for GORE® STA-PURE™ Flexible Freeze Container

Single-use GORE® STA-PURE® Flexible Freeze Containers are intended for handling, transport and storage of frozen bulk drug substances, particularly at freeze temperatures down to -80°C (-112°F).  

This document is available upon request.

Validation Guide: GORE® IMPROJECT® Plungers

A comprehensive guide for validating these plungers for use in bare-glass (non-siliconized) pre-filled syringe barrels. GORE® IMPROJECT® plungers can help to protect the stability of complex, silicone-sensitive biologics, while providing consistent drug delivery performance over time. This document is available upon request.