Gore Announces New Lyophilization Product


Elkton, Maryland (October 23, 2006) - W. L. Gore & Associates, Inc., has released a new freeze-drying container that is ideal for research and stability studies, scale-up evaluations and multi-product lyophilization operations. GORE(TM) LYOGUARD® Freeze-Drying Containers provide similar product protection as the GORE(TM) LYOGUARD® Freeze-Drying Trays. These new containers, which hold up to 60 ml of product, are single-use, autoclavable packages with removable, screw-on lids that provide easy access to the pharmaceutical cake.

Unlike traditional open trays used in lyophilization, GORE(TM) LYOGUARD® Freeze-Drying Products contain and protect pharmaceutical compounds in a "closed" system, while at the same time providing a means for sublimation of solvent (normally water) to occur. This closed-system design provides several benefits in a multi-product environment - the design reduces the risk of cross-contamination and product loss due to fly-out. It also reduces, if not completely eliminates, the time-consuming process of cleaning the freeze-drying equipment as well as any cleaning validation that was necessary.

GORE(TM) LYOGUARD® Freeze-Drying Containers improve consistency and accuracy of research and test results because they are non-particulating, eliminate fly-out, and prevent cross-contamination. The combination of these features means that potential sources of research error are minimized, and multiple products can be processed at the same time without compromising the quality of results.

The success of this design is due to Gore's proprietary expanded polytetrafluoroethylene (ePTFE) membrane that is incorporated into the container's removable lid. The microporous structure of ePTFE allows vapor to flow freely in and out of the container and prevents contaminants from entering the container, thus assuring the product's integrity. The bottom part of the container is made of polypropylene and a medical-grade film that comply with FDA regulation 21 CFR 177.1520. The flexibility of the film enables the containers to conform to dryer shelves, thereby transferring heat efficiently and uniformly.

According to Gore's global product manager Joseph Brendle, one of the biggest benefits of using GORE(TM) LYOGUARD® Freeze-Drying Containers is the increased safety in the research environment. Brendle says, "Many of today's pharmaceutical research programs are using more potent active ingredients, and these pose a challenge to manufacturers committed to worker safety. GORE(TM) LYOGUARD® Freeze-Drying Containers can be an integral part of programs that reduce workers' potential exposure to potent compounds without requiring major changes to manufacturing processes or large capital investments."

About W.L. GORE & Associates, Inc.

W. L. Gore & Associates, Inc., has made its name by creating innovative, technology-driven solutions, such as high-performance GORE-TEX® fabrics, medical devices that treat aneurysms, guitar strings and electronic cables used in space exploration. Gore products have set new standards for reliability and performance in the consumer, industrial, electronic, pharmaceutical, medical and surgical markets. A privately held company with annual sales approaching $2 billion, Gore is committed to perpetuating its nearly 50-year tradition of product innovation. The company operates more than 45 facilities worldwide with headquarters in Newark, Delaware, USA. For more information about the complete line of GORE(TM) LYOGUARD® Freeze-Drying Products, contact Joseph F. Brendle at W. L. Gore & Associates, Inc., at +1.410.506.8956, or visit the Gore website at http://www.gore.com/lyoguard.

Media Contact:
Gretchen Adams, Marketing Communications
+1.410.506.8852

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