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CAR-T cells, for example, have shown remarkable overall response rates in treating blood-borne cancers, such as acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). Immunotherapies have the potential to revolutionize care and outcomes for patients fighting hematologic malignancies.

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How to thaw frozen cells in the CAR T workflow Please visit Cytiva’s website or contact us for more information on variant features, availability, and pricing. Cytiva reserves the right to change plans and timing in regards to the release of any product.įor details on the differences and similarities between the variants, see the Appendix. The VIA Thaw MD1000, available only in determinate countries, is a Medical Device intended for the automated thawing of a single frozen cryobag containing a cell suspension or other biological products. It is not intended for clinical procedures or for diagnostic purposes. VIA Thaw L1000 is intended for research or manufacturing use only. *Note: Cytiva’s VIA Thaw L1000 and MD1000 are variants of CB1000 model and offer additional flexibility for different use cases. Overall, the VIA Thaw™ unit showed comparable performance to a water bath when thawing gene-modified T cells, supporting its use in CAR-T cell therapy workflows. Pre- and post-thaw viability, recovery, and phenotype were measured and compared between the two thawing methods. After thaw, the cells were expanded in small scale for 6 d to assess post-thaw reactivation as a surrogate measure of T-cell proliferation in vivo. Viable cell density and phenotype were analyzed across all conditions. Cryobags were then thawed using either the VIA Thaw™ system or a water bath. The cells were formulated in CryoStor™ CS10 and cryopreserved at two volumes in a VIA Freeze™ controlled-rate freezer followed by transfer to liquid nitrogen vapor for storage. Cells were then harvested, volume-reduced, and washed using the Sefia™ Cell Processing instrument. T cells were expanded post-activation and post-transduction with an enhanced green fluorescent protein (eGFP)-encoding lentiviral vector (LVV) in a Xuri™ Cell Expansion System W25. A model CAR T workflow was used for all upstream cell manufacturing. Here, we compare the performance of the VIA Thaw CB1000* (predecessor to the VIA Thaw™ L1000 and VIA Thaw™ MD1000 – see “Appendix – Demonstration of VIA Thaw L1000/CB1000 comparability”) to thawing in a water bath.

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Finally, these systems help improve productivity by eliminating the labor involved in preparing, validating, manually thawing, and transcribing manual thaw records.

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Chronicle™ software can also connect all VIA Thaw™ systems, which standardizes thawing across connected units. Units synchronized with the web-based Chronicle™ software platform can receive the thawing record and unite this data with the sample’s complete electronic batch record.

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In addition, the VIA Thaw™ series electronically records the thawing run - a key feature, as tracing the history of a sample from collection to patient delivery is critical for GMP manufacture. Instead of fluid, a precision-machined aluminum bed acts as a heat source, reducing the risk of water-borne contamination. These innovative and automated thawing units rely on temperature sensors to actively monitor cell therapy sample conditions in real time, leading to better control, reduced manual intervention, and less subjectivity in the thawing process. To address the shortcomings of commonly used thawing systems, we developed the VIA Thaw™ series. In addition to the inability to log data or connect digitally, other limitations to many of the dry thawing systems that are available include subjective or preset thaw times instead of automatic, adjusted, and sample-specific thawing. Dry thawing systems are not commonly used, as most options are not compatible with GMP manufacture. Determining thaw times in a water bath is also subjective, leading to variability.

This method introduces the risk of exposure to water-borne contaminants, adding to product quality concerns. After cryopreservation, cell therapy products are commonly thawed manually in a water bath. CAR-T cell therapy workflows need standardized and automated unit operations to improve process efficiency and reproducibility.