Case Study: Ensuring CCI of Gene Therapy Cancer Vaccine during Deep Cold Storage

This case study describes how a gene therapy manufacturer handled a possible Container Closure Integrity (CCI) issue due to deep cold storage at -80°C. The product was in clinical trial when the manufacturer discovered potential breaches in CCI. Scheduled clinical trial was halted and product batches were put under quarantine. Discussions with the national regulator were started and a root cause analysis was initiated with the objective to characterize the problem and propose corrective actions.