NEWARK, Del. (August 21, 2018) – W. L. Gore & Associates, Inc. ("Gore"), a global materials science company, will debut its new GORE® STA-PURE™ Flexible Freeze Containers at the 2018 BioProcess International Conference and Exhibition (BPI). Gore will be in Booth 1531 at the event, to be held September 4–7, 2018, at the Hynes Convention Center in Boston, MA.
Joe Cintavey, Product Specialist, will present "Minimizing Risk of Product Loss in Cold Chain Handling: An innovative single-use container for handling, storage & transport of bulk drug substances" on September 5 at 12:20pm during the luncheon sessions. The presentation will focus on the challenges of utilizing single-use containers throughout the biologics cold chain and introduce a new solution specifically designed to address these challenges in existing cold chain handling technologies.
GORE STA-PURE Flexible Freeze Containers are designed to protect high-value bulk drug substances from container breakage or leakage during frozen handling—typically the most vulnerable stage of the product’s journey from processing to delivery. 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. It also offers users the convenience and scalability of a single-use system that efficiently uses freezer space.
Gore conducted extensive customer interviews to fully understand the shortcomings of current commercially available solutions and the complex cold chain challenges facing today’s biomanufacturers. Manufacturers identified bag breakage and concerns over extractables and leachables in single-use materials among their biggest issues. As part of the product development process, Gore performed in-depth drop-testing, freeze-thaw cycling, distribution testing, and materials testing. The result is the GORE STA-PURE Flexible Freeze Container, a highly durable single-use freeze container with a low extractables profile.
"The necessity of cold chain handling for biologics has introduced many new challenges for biomanufacturers," said Joe Cintavey, Product Specialist for Gore PharmBIO Products. "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."
About Gore PharmBIO products
Our technologies, capabilities, and competencies in fluoropolymer science are focused on satisfying the evolving product, regulatory, and quality needs of pharmaceutical and bioprocessing customers, and medical device manufacturers. GORE STA-PURE Flexible Freeze Containers, like all products in the Gore PharmBIO Products’ portfolio, are manufactured in a manner that adheres to relevant current Good Manufacturing Practices (cGMP) as defined in the stringent Gore PharmBIO Products’ quality system which is certified to ISO 13485 and ISO 15378.
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Founded in 1958, Gore has built a reputation for solving complex technical challenges in the most demanding environments — from revolutionizing the outerwear industry with GORE-TEX® fabric to creating medical devices that improve and save lives to enabling new levels of performance in the aerospace, pharmaceutical and mobile electronics markets, among other industries. The company is also known for its strong, team-oriented culture and continued recognition from the Great Place to Work® Institute. Headquartered in Newark, Del., Gore employs approximately 9,500 Associates and generates annual revenues that exceed $3 billion. www.gore.com