Reducing Product Loss In The Biomanufacturing Cold Chain: The Critical Nature Of A Durable Primary Packaging Solution

By Joe Cintavey, Product Specialist, PharmBIO, W.L. Gore & Associates, Inc.

Biopharmaceutical manufacturing is becoming more complex, with new risks that can jeopardize the supply of valuable bulk drug products. Manufacturers must consider several factors when it comes to ensuring the safe transport of their valuable products through cold chain storage and transportation. Traditional single-use bags are vulnerable to damage at multiple points in the cold chain. Although secondary and tertiary packaging can help protect tubes and connectors and facilitate handling, primary packaging — that which has direct contact with sensitive drug substances — should be the focus of efforts to protect these substances in extreme conditions.

GORE STA-PURE Flexible Freeze Containers are built from the ground up for handling, transport, and storage of frozen bulk drug substances at -80°C (-112°F). Unlike other bags that may become brittle and fragile when frozen, Gore’s next-gen containers minimize the risk of cracks, breaks, or leaks, bringing extreme strength and durability to your cold chain. Because they are made with expanded polytetrafluoroethylene, a chemically inert, chemically stable material, with low extractables and high levels of purity.

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