Webinars

Rapid sterility testing of Gene and Cell Therapy products Webinar

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DATE

16 June 2020

 

Speakers

Lori Daane
Pharma Microbiology Scientific Director at bioMérieux 

Dr. Michael J. Miller
President of Microbiology Consultants, LLC 

 

OVERVIEW

Gene and cell therapy products, also known as advanced therapy medicinal products (ATMP), present unique challenges for Quality Control release testing due to their very short shelf life, fast medical need for dosing patients and limited availability of product for sterility testing. As such, meeting the requirements for existing compendial sterility test methods is often difficult, if not impossible, to achieve.

This web seminar will focus on recent regulatory policy changes, compendial recommendations and industry best practices for alternative approaches to sterility testing of gene and cell therapy products. A review of Ph. Eur. 2.6.27 (Microbiological Examination of Cell-Based Preparations), USP informational chapter <1071> (Rapid Sterility Testing of Short-Life Products: A Risk-Based Approach), EU Guidelines on Good Manufacturing Practice Specific to ATMPs and FDA’s Guidance on Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications will be provided.

The information provided will be supported by case studies on selecting a relevant sterility test sample and an appropriate sample size for the release of gene and cell therapy products.

 

 

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Written by
Dr. Lori
DAANE

Scientific Affairs Director Healthcare | bioMérieux

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Written by
Michael
J. Miller, Ph.D.

Pharmaceutical microbiology consultant
Rapid microbiological methods expert

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