Comparison Of Rigid Polymer Vials And Flexible Bags For The Cryopreservation Of T Cells

By Samuel A. Molina, Katie Glen, Jon Harriman, Crystal Kraft, Robert Thomas, Alexander Lyness

The commercialization of cell-based drug products drives a critical need for the refinement of storage and handling procedures to ensure integrity is maintained from manufacture until administration to the patient. Autologous cell therapy applications currently call for large volume cell suspensions administered via intravenous injection, making cryogenic flexible bags an attractive containment solution. However, numerous challenges still exist when using plastic bags made from materials such as ethylene vinyl acetate (EVA) and fluorinated ethylene propylene (FEP) that include filling difficulties, product loss due to dead volume, subvisible particulate loads, and cracking of the flexible material during cryogenic handling increasing the risk of breakage. Cyclic olefin polymer (COP) vials with rubber stopper-aluminum seal closures have desirable container closure integrity, material properties, and low particulate levels suitable for cell therapy product applications. This work evaluates the performance of rigid 50 mL COP vials as an alternative for cryogenic storage of T cells compared to existing flexible cryogenic bags. The results are timely given the emerging packaging requirements and larger batch sizes anticipated for allogeneic cell therapies under clinical development.