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Gore’s new flexible freeze containers are designed to protect high-value drug substances from container breakage or leakage.
W. L. Gore & Associates, a global materials science company, debuted its new GORE STA-PURE flexible freeze containers at the 2018 BioProcess International Conference and Exhibition (BPI) held in Boston, MA, on Sept. 4–7, 2018. These flexible freeze containers are designed to protect high-value bulk drug substances from container breakage or leakage during frozen handling, which is typically a vulnerable stage in the product’s transport.
The containers are constructed of a proprietary high-strength fluoropolymer material that is durable after freezing at -86 °C (-123 °F). In addition to durability, the container’s chemically inert, biocompatible, high-purity fluoropolymer composite film has a low extractables profile and offers users the convenience and scalability of a single-use system that efficiently uses freezer space, the company states.
Development of the new product resulted from Gore’s evaluation of customer interviews it had conducted to fully understand the shortcomings of current commercially available solutions and the complex cold-chain challenges facing biomanufacturers. Manufacturers identified bag breakage and concerns over extractables and leachables in single-use materials among their biggest issues. In the product development process, Gore performed in-depth drop-testing, freeze-thaw cycling, distribution testing, and materials testing.
"The necessity of cold-chain handling for biologics has introduced many new challenges for biomanufacturers," said Joe Cintavey, product specialist for Gore PharmBIO Products, in a company press release. "We look forward to introducing this product to our colleagues at BioProcess International and speaking more about its role in preventing product loss and overcoming the limitations found in existing solutions on the market."
Source: W. L. Gore & Associates