Vial Containment Systems For Gene And Cell Therapies

By Margaret A. Craig

Cell and gene therapies are a rapidly growing field, with a projected growth rate of 24.7% over the next decade. These therapies require specialized containment systems to maintain container closure integrity (CCI), especially at extremely low temperatures. West Pharmaceuticals conducted a study to evaluate the performance of two vial-stopper-seal combinations using Daikyo Crystal Zenith (CZ) vials, fluoropolymer-laminated elastomer stoppers, and Flip-Off CCS seals.

The components were selected for evaluation based on their low risk to drug product performance. The study aimed to determine if these systems could maintain CCI over an extended period at ultra-low and cryogenic temperatures.

The study findings suggest that the CZ vial-stopper-seal combinations offer a viable solution for the challenges associated with low-temperature storage of cell therapy drug products. The systems are scalable for commercial success and have the potential to meet the unique requirements of cell and gene therapies.