Container Closure Integrity Evaluation For Cell And Gene Therapies

With the growth of gene and cell therapies, there is an increased need to characterize container closure systems (CCS) at the low temperatures experienced during their lifecycles: ultra-low (-80°C) for genes and cryogenic (-180°C) for cells. West’s Integrated Solutions platform includes the state-of-the-art container closure integrity (CCI) capabilities needed for these therapies.

The FDA guidance for industry Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products^* highlights the role of CCI evaluation in stability protocols for sterile drug products.

Explore which methods are well suited to evaluate CCI of CCS for gene and cell therapy products: