Development of a Novel Cold Chain Tubing, FP-FLEX™, and Single- Use Freezing Bag for Working Cell Banks Enabling Closed-System Processing to Temperatures as Low as -196°C

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Charter-upstream-2015-smWorking cell banks (WCB’s) are commonly applied to initiate cell culture manufacturing campaigns for production of therapeutic proteins. These campaigns typically begin with inoculation of cells previously cryopreserved in vials. While vials are typically used to establish WCB’s and initiate manufacturing campaigns, they are not optimal for the growing demands of commercial production. Vials are small and filling/removal is performed through an open cap. This process leads to numerous manual operations and culture vessels, resulting in contamination risks and potential campaign-to-campaign variability. Single-use bags would be ideal for WCB applications, but adoption has not been observed as current available bags and tubing don’t hold up to the demands (break; can’t be welded) when stored/transported at cryogenic (-196°C) temperatures. To overcome these challenges, novel thermoplastic tubing was developed to balance both the flexibility and robustness demands of cryogenic storage and tube welding characteristics necessary for sterile closed-system processing. The new FP-FLEX™ tubing can be frozen and maintained at cryogenic temperatures, thawed and sterile welded to other thermoplastic tubing (such as C-Flex®).