NEWARK, Del., April 16, 2020 /PRNewswire/ -- W. L. Gore & Associates, Inc. ("Gore"), a global materials science company, announced today that its ground-breaking GORE® STA-PURE Flexible Freeze Container has been recognized as one of the 16 Innovation Award winners by industry magazine, The Medicine Maker. These containers protect bulk drug substances during cold chain handling to temperatures of -86°C (-123°F).
The Medicine Maker Innovation Awards recognize "the most groundbreaking drug development and manufacturing technologies released onto the market over the course of the year. All entries are evaluated carefully based on their potential impact on drug development and manufacture."
GORE® STA-PURE Flexible Freeze Containers are constructed of a high-purity, biocompatible fluoropolymer composite film—selected for its durability and low extractables profile. Gore has also used a patented design engineered to maximize container strength. Whereas some companies supply bags based on material properties of the film only, Gore developed performance testing in alignment with how the product will actually be used. For example, in impact testing, bags were filled with solution, frozen to -86 C (-123F) and then dropped from a height of 3 feet. In addition, the containers did not crack or break, even through five successive freeze/thaw cycles.
The Medicine Maker noted that their choice of the GORE® STA-PURE Flexible Freeze Containers as an award winner was based on its potential impact on the industry. "Pharmaceutical manufacturers need durable, high-purity materials for storage," the award description explains. "Traditional polymer-based containers can become brittle at low temperatures, causing them to break or leak. Manufacturers need solutions that help minimize the risk of container failure and enable them to securely transport frozen bulk drug material."
Joe Cintavey, Product Specialist at Gore PharmBIO Products, elaborated, noting, "Traditional polymer-film-based, single-use bags have several vulnerabilities. Besides the risk of lost bulk drug substance during cold chain handling, transport or storage, materials commonly used in disposable packaging contain extractables and leachables that may impact the overall stability and efficacy of the bulk drug substance."
"The strength, durability and high purity of GORE® STA-PURE Flexible Freeze Containers make them ideal for high-value biopharmaceutical bulk drug substances such as vaccines, monoclonal antibodies, and antibody drug conjugates," Cintavey added. "We're pleased to be recognized by The Medicine Maker Innovation Awards for our important contribution to the pharmaceutical industry."
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world's highest peaks to the inner workings of the human body. With more than 10,500 Associates and a strong, team-oriented culture, Gore generates annual revenues of $3.7 billion.
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