Vial Containment Systems For Gene Therapies

By Margaret A. Craig, Manager, Scientific Communications; Rui Li, Ph.D., Senior Scientist, R&D, Cryobiology; and T. Page McAndrew, Ph.D., Director, Scientific Communications

Gene therapies are expensive to manufacture, sensitive to container interactions, and routinely stored at -80°C — conditions that expose weaknesses in conventional vial-stopper-seal systems. The choice of containment material affects not just sterility, but viral vector recovery, leachables exposure, and particle burden.

This e-book presents research evaluating cyclic olefin polymer (CZ) vial containment systems against borosilicate glass and polypropylene alternatives across four performance dimensions. Studies with adeno-associated virus, adenovirus, and lentivirus vectors show CZ systems match or exceed polypropylene on functional vector recovery after freeze-thaw and outperform borosilicate glass.

Container closure integrity data from two years of storage at -80°C shows no breach of any sample. Material characterization work addresses thermal expansion mismatch, particle generation, and leachables — factors that take on added significance for high-value, low-volume biologics. The research also considers how fill volume, assembly conditions, and secondary packaging affect system performance in real-world cold-chain scenarios. Explore the full analysis to inform containment system selection for your gene therapy program.