Proof of concept of a fully enclosed CAR-T process without use of a biosafety cabinet

This proof-of-concept study evaluated the feasibility of using CellSeal Connect vials as closed-system alternatives to conventional cryovials, with the goal of eliminating reliance on biosafety cabinets (BSCs) during CAR-T manufacturing. Enriched T cells from healthy donors and lentiviral vectors were filled and cryopreserved in both CellSeal Connect vials and standard cryovials, then used in a CAR-T process. Additionally, BioLife Solutions’ CellSeal® CryoCases, which are a rigid and transparent primary storage container, were evaluated as a closed system option for filling final drug product. Results demonstrated comparable cell expansion, viability, and transduction efficiency between cells cryopreserved in the CellSeal Connect vials and standard cryovials. Additionally, post-thaw final drug product was similar between cryovials and CellSeal CryoCases. These findings support the feasibility of eliminating BSC use in standard CAR-T manufacturing, which can potentially reduce contamination risk, facility complexity, and cost in CAR-T production.