Single-Use Systems for Storing and Shipping Frozen Drug Materials

Using presterilized, single-use freeze–thaw systems instead of traditional freeze–thaw platforms that include stainless-steel tanks and bottles can help biomanufacturers manage the quality of their drug substances. Single-use assemblies reduce the risk of cross-contamination, simplify dispensing, and decrease the number of manual interventions during freezing, thawing, handling, and shipping. However, implementing a freeze–thaw process requires careful testing of the physical and thermal properties of single-use systems and related aseptic connectors as well as assessment of drug-substance quality and stability. Such evaluation has become even more critical than ever as drug companies continue moving their freeze–thaw processes to the lower end of the industry-standard range (–20 °C to –80 °C ).

In this BPI Special Report, Derek Pendlebury of Colder Products Company (CPC) explores criteria for selecting and implementing aseptic connectors that perform well in extreme temperature conditions. Read the report now to learn how CPC designs, studies, and validates its AseptiQuik line of aseptic connectors to ensure robust operation during drug product freeze–thaw processes. Learn how adopting a simple-to-operate single-use connection technology can reduce process complexity and drive a standardized approach to future platforms.

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