The implementation of rapid microbiological methods (RMM) has gained significant momentum over the past few years. In particular, the ATMP segment has a desire to release cell and gene therapies using rapid sterility tests to accommodate patient needs and very short drug product shelf life. Additional rapid sterility testing needs are now being fueled by companies who are developing vaccines for COVID-19 clinical trials. In this webinar, Dr. Michael J. Miller will present an overview of past and future microbiological methods, the current regulatory landscape for rapid sterility testing including recent policy changes, applicable technologies and validation strategies.

Hora

16:00 - 17:00 hs GMT+1

Organizador

BioPharma Asia Magazine
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