ABOUT W.L. GORE & ASSOCIATES, INC.

In a highly regulated industry marked by economic pressures and drug development and processing challenges, Gore provides technology-driven products and process components designed for efficiency, reliability and contamination control.

Single-use GORE® STA-PURE™ Flexible Freeze Containers are intended for storing and transporting bulk drug substances after freezing at -86°C (-123°F).

Single-use storage containers have many advantages to biopharmaceutical manufacturers and are commonly used throughout drug production. However, there are vulnerabilities associated with traditional polymer-film-based disposable bags:

  • They can become brittle and fragile at cold temperatures, increasing the risk of loss during cold chain handling, transport or storage.
  • Extractables and leachables from materials commonly used in disposable packaging are a concern.

NOW, GORE MATERIALS SCIENCE DELIVERS A SOLUTION TO BOTH ISSUES
Single-use GORE STA-PURE Flexible Freeze Containers are intended for storing and transporting bulk drug substances, after freezing at -86°C (-123°F).

The strength, durability and high purity of the materials of construction make GORE STA-PURE Flexible Freeze Containers ideal for high-value biopharmaceutical bulk drug substances such as:

  • vaccines
  • monoclonal antibodies
  • antibody drug conjugates (ADCs)
  • And a robust validation package and available technical support are offered to make initial evaluation easier

Utilizing our advanced materials understanding, we’ve engineered a highly durable proprietary fluropolymer (PTFE) composite film designed specifically for bulk biopharmaceutical cold chain applications.

GORE STA-PURE Flexible Freeze Containers are sold as an assembly and are suitable for both plate and blast freezers in sample, small, medium and large sizes. Maximum fill volumes vary by freezing method. Contact us for tubing and connector options.

Introducing the GORE® STA-PURE® Flexible Freeze Container Stability Bag

W.L. Gore & Associates, Inc.’s PharmBIO division is excited to announce the launch of the GORE® STA-PURE® Flexible Freeze Container Stability Bag.  The stability bag is a product line extension to the GORE STA-PURE Flexible Freeze Container intended for handling, transport and storage of biopharmaceutical intermediates after freezing at temperatures as low as -86 C.  The 50 mL container can be supplied with Luer Lock connectors for easy under hood filling. Colder AseptiQuik® S connectors for aseptic filling of small volumes are also available to support stability testing, phase 1-3 clinical testing or sampling during GMP production.  The stability bag is constructed using the same proprietary 100% fluoropolymer PTFE film as our GORE STA-PURE Flexible Freeze Container product line. Supplied inside two Tyvek® pouches, the stability bag is sterile certified and ready to use. For more information, visit our website to review the GORE STA-PURE Flexible Freeze Container datasheet.

GORE STA-PURE Flexible Freeze Containers have proven strength and durability at frozen temperatures and maintain integrity after multiple freeze/thaw cycles.  If the risk of product loss due to container breakages or leaks are a concern throughout your cold chain, you can contact a Gore associate today for more information or samples of the GORE STA-PURE Flexible Freeze Container product line.

VIDEOS

  • Learn how the GORE® STA-PURE® Flexible Freeze Container may help minimize the risk of product loss when storing and transporting bulk drug substances at low temperatures.

  • Single-use GORE® STA-PURE® Flexible Freeze Containers are intended for storing and transporting bulk drug substances, particularly at temperatures down to -80°C (-112°F).

  • How many containers are you willing to lose? This animated video demonstrates how the GORE® STA-PURE® Flexible Freeze Container helps minimize the risk of product loss in the cold chain.

  • In this Q&A with Dr. Bill Barrett, Product Specialist for GORE® Protein Capture Devices with Protein A discusses how Gore used its innovative membrane technology to improve productivity in mAb purification.

  • In this Q&A with Dr. Bill Barrett, Product Specialist for GORE® Protein Capture Devices with Protein A considers the impact Gore’s affinity chromatography columns could have in drug discovery applications.

  • In this Q&A with Dr. Bill Barrett, Product Specialist for GORE Protein Capture Devices with Protein A discusses the speed and capacity advantages of using the device, as well as potential uses in continuous chromatography.

  • In this Q&A with Dr. Bill Barrett, Product Specialist for GORE® Protein Capture Devices with Protein A discusses the climate in the pharmaceutical market and describes some of the productivity challenges scientists are facing in antibody purification today.

  • In this Q&A with Dr. Bill Barrett, Product Specialist for GORE® Protein Capture Devices with Protein A talks about why he finds working to improve drug research processes with new technology so exciting.

  • In this Q&A with Dr. Bill Barrett, Product Specialist for GORE® Protein Capture Devices with Protein A discusses the innovative technology used in the membrane-based chromatography columns and where the technology is headed in the future.

  • Can your tubing take the pressure? Durable. Resilient. Reliable. The unique ePTFE and platinum-cured silicone composite structure of GORE® STA-PURE® Pump Tubing, Series PCS for peristaltic pumps is ideal for critical drug processing applications. See for yourself how GORE STA-PURE Pump Tubing performs compared to conventional silicone tubing. This is just one product in a portfolio of products designed to meet the evolving needs of pharmaceutical and biopharmaceutical manufacturers.

CONTACT INFORMATION

W.L. Gore & Associates

402 Vieve's Way

Elkton, MD 21921

UNITED STATES

Phone: 410-506-8272

Contact: Bill Barrett

PRODUCTS

  • Utilizing our expertise with fluoropolymers and knowledge designing healthcare solutions, Gore is now developing materials-based solutions for the pharmaceutical and OEM medical device manufacturers.

  • 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.

  • See how the 50-milliliter (ml) stability container assembly supports handling, transport and storage of biopharmaceutical intermediates, after freezing at -86°C (-123°F).

  • Single-Use GORE STA-PURE Flexible Freeze Containers are intended for handling, transport and storage of frozen bulk drug substances, after freezing at -86°C (-123°F). Unlike other bags that may become brittle and fragile when frozen, GORE STA-PURE Freeze Containers resist cracks, breaks or leaks if accidentally dropped.

  • Specially fitted disposable Hard-shell Carriers, suitable for plate or blast freezers, are available as accessories. They are designed to maximize freezer space, make handling easier and further protect tubing in the Container Assembly.

  • GORE Protein Capture Devices with immobilized Protein A are intended for affinity purification of monoclonal antibodies in drug discovery applications. The devices are offered in 1.0 mL and 3.5 mL and use a unique expanded polytetrafluoroethylene (ePTFE) membrane composite that provides a binding capacity advantage at high flow rates and improves the speed of purification.

  • GORE Protein Capture Devices, 9.0 mL with Protein A are intended for the affinity purification of monoclonal antibodies from clarified harvest streams in process development, pre-clinical and early clinical applications. The devices use a unique expanded polytetrafluoroethylene (ePTFE) membrane composite that provides a binding capacity advantage at high flow rates and improves the speed of purification.

  • GORE® STA-PURE® Pump Tubing Series PCS enables reliable peristaltic pump operation in critical pharmaceutical and bio pharmaceutical processing applications. The unique composite structure of the tube adds strength and high flex durability for greater security against rupture under challenging conditions, up to 100 psig.

  • GORE® STA-PURE® Pump Tubing Series PFL enables reliable peristaltic pump operation in critical pharmaceutical and biopharmaceutical processing applications that include aggressive chemicals. The unique, chemically inert composite of Series PFL increases its durability for greater security against catastrophic failure due to rupture or chemical attack.