Evaluation Of Daikyo Crystal Zenith® Vials Versus Ethylene Vinyl Acetate Cryobags For The Cryopreservation Of Therapeutically Relevant T Cells

In this exploratory study, the suitability of commercially available flexible and rigid 50 mL container systems has been evaluated using therapeutically relevant human CD3+ T cells representative of apheresis starting material in the process of manufacturing an allogeneic gene-modified CAR-T cell therapy. Data has been generated using a Daikyo Crystal Zenith^® (CZ) Ready-to-Use (RU) cyclic olefin polymer (COP) vial container system alongside a commercially available flexible ethylene vinyl acetate (EVA) blood bag rated for use in cryogenic temperatures. This data aids our understanding of the effects of cryopreservation on therapeutically relevant T cells when using COP vials for cryostorage.

The results demonstrate the utility of a commercially available, low-particulate, rigid, COP-based container system solution and demonstrates proof-of-concept that vials are suitable for cryogenic storage of cells in larger volumes than previously demonstrated, indicating 50 mL COP vials as a credible option for single- and multi-vial autologous and larger scale allogeneic cell therapy containment.