Manufacturing and Bioprocessing – Biomolecular
2019 PharmSci 360
Annie Leahy, M.S.
MilliporeSigma
Regulatory guidance requires product-specific microbial retention testing on sterilizing filters to confirm the suitability and compatibility of the filter for the process conditions and stream. In practice, performing such testing is challenging particularly with early stage clinical products where material is limited. The implementation of a risk-based, Quality by Design approach to microbial retention testing supports a paradigm that would obviate the need for product-specific testing. Process and product parameters were evaluated to determine the impact of these changes on microbial retention performance of sterilizing filters.