Qualifying a New System for Sterility and Microbial Detection of Biotherapies: Lessons Learned from the Trenches

Proposed Session Description: Sterility testing and microbial detection are required for the development and production of human cellular and tissue-based products (HCT/P) and cell & gene therapies. Sterility testing ensures that a product is free from viable microorganisms, while microbial detection identifies the presence of microorganisms in a sample. Sterility testing is a critical step in the manufacturing and final product release to ensure the safety and efficacy of biotherapies. Microbial detection, on the other hand, is used to assess the quality of products that may not be sterile but still contain microorganisms that could pose a risk to health. It is commonly used in the manufacturing and release of HCT/P products. This session will cover lessons learned when qualifying a new system for sterility testing and microbial detection of HCT/Ps and cell & gene therapies. It will cover a real life example of a qualification study requiring multidisciplinary efforts from physicians, front line lab techs, information technologists, and quality & regulatory professionals. This session will also cover how to perform and interpret sterility testing and microbial testing comparison studies with current and compendial methods. Topics covered will include compendial method comparisons, differences between qualifying a sterility/microbial detection tests & serological/NAT testing, statistical methods (Most Probable Number, Non-inferiority, t- test), regulations (USP 71, 72, 1223), organism selection, qualification sample size, choosing appropriate culture vials, software integration, automation, resource prioritization, and qualification risk analysis.