Regulatory Strategies For Rapid Sterility Testing...

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Presented by

Dr. Michael J. Miller, at Microbiology Consultants, LLC and Lori Daane, at bioMérieux

About this talk

Full Title: Regulatory Strategies For Rapid Sterility Testing of Gene and Cell Therapy Products The need to utilize rapid sterility testing is gaining momentum within our industry, especially for short-life drugs with an immediate patient need, such as advanced therapy medicinal products (ATMPs; cell and gene therapies). This webinar will explore the challenges of manufacturing and releasing ATMPs and the benefits of implementing rapid sterility test strategies. In particular, we will discuss valorous global regulatory initiatives and policy changes that support the use of rapid sterility tests for these types of products, as well as the introduction of compendial chapters providing guidance for validation and implementation. We will finish with case studies on how rapid sterility validation studies may be performed.

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