Special Topic 1: Deep Cold Storage

Studies have shown that ultra-cold temperatures (-70° C and colder) can introduce risk to the container closure integrity (CCI) of a sealed sterile product vial. This session will present and describe a robust approach for mitigating this risk using work done for the BNT162 mRNA vaccine as a case study. The work included the application of QbD principles to generate robust analytical data on the primary packaging system in the development phase, and then using this data for risk-based qualification and control of the vial sealing process. The holistic approach described and discussed in this session is useful for upcoming therapies needing an ultra-cold chain for storage and distribution.