Cryopreserving CAR-T cells in a novel rigid container maintains their phenotype and function compared to conventional cryobags and cryovials

CAR-T cell therapies are rapidly emerging as an effective treatment and even cure for malignant cancers. How these therapies are cryopreserved is essential to preserving their cancer killing function and how they are shipped is important in reliably delivering these life-saving treatments to patients. Here, we compared CAR-T cells cryopreserved in a novel, rigid-walled container—the CellSeal® CryoCase™ (CryoCase)—to those cryopreserved in the conventional cryobags and cryovials used in the industry. We found that CAR-T cells can be effectively cryopreserved in the CryoCase using the same controlled rate freezing profiles and methods used for standard cryobags and cryovials. CAR-T cells cryopreserved in the CryoCase maintained cell viability and cell recovery above 85%, similar to CAR-T cells cryopreserved in both cryobags and cryovials. Expression of the chimeric antigen receptor (CAR) on T cells was similar across all cryopreservation containers tested. CAR-T cell phenotype was also comparable across the different cryogenic containers, with no significant difference in the distribution of CD4+ helper T cells and CD8+ cytotoxic T cells, as well as naïve and memory T cells. The CryoCase was also compatible when tested in a fully automated and closed CAR-T manufacturing process, where it provided a robust and easy-to-use solution for product fill and finish, with critical quality attributes identical to CAR-T cells stored in cryobags and cryovials. Collectively, these results offer insight into a novel cryopreservation process and container for CAR-T cells, and explore how the fitness and function of CAR-T cells compares across the different containers that they are cryopreserved and stored in.

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