Cryogenic storage challenges for container-closure systems
Cell and gene therapy products require ultra-low temperatures to maintain stability and prevent degradation. However, these extreme conditions can impact vial-based container-closure systems, posing a risk to drug safety. While cryopreservation keeps the product stable, extends shelf life, and ensures stability throughout the supply chain, differences in thermal expansion between glass vials, rubber stoppers, and aluminum seals can lead to contraction, potential leakages, and CCI failures. A validated container-closure system is essential to maintaining integrity throughout storage and transport.
Read the full whitepaper to discover best practices to ensure CCI in cryogenic storage and avoid costly recalls!