Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and Cell Therapy Products

23rd May 2019 | 10.00 am EST | Dr. Michael J. Miller, President of Microbiology Consultants, LLC and Lori Daane Pharma Microbiology Scientific Director at bioMérieux |WATCH FOR FREE

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.


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

Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology, contamination control and the validation and implementation of rapid microbiological methods (RMM). He is currently the President of Microbiology Consultants, LLC ( and owner of, an educational website dedicated to the advancement of rapid microbiological methods within a variety of healthcare, pharmaceutical, consumer and related industry sectors.

For 30 years, he has held numerous R&D, manufacturing, quality, business development and executive leadership roles at Johnson & Johnson, Eli Lilly and Company and Bausch & Lomb. In his current role, Dr. Miller consults with multinational companies in providing technical, quality, regulatory and training solutions in support of rapid methods, sterile and non-sterile pharmaceutical manufacturing, contamination control and remdiation, environmental monitoring, sterilization and laboratory operations.

Dr. Miller has authored more than 100 technical publications and presentations and is the editor of PDA’s Encyclopedia of Rapid Microbiological Methods. He currently serves on the editorial and scientific review boards for American Pharmaceutical Review, European Pharmaceutical Review and the PDA Journal of Science and Technology. Dr, Miller also was the chairperson during the revision of PDA Technical Report #33: Evaluation, Validation and Implementation of New Microbiological Testing Methods. He currently serves as an advisor to the USP Microbiology Expert Committee in the area of rapid sterility testing.

Dr. Miller holds a Ph.D. in Microbiology and Biochemistry from Georgia State University (GSU), a B.A. in Anthropology and Sociology from Hobart College.

Sponsored by bioMérieux

bioMérieux helps our clients unlock greater value from their organizations with expert consultation and a complete line of diagnostic solutions that enable more rapid, confident results. Clients benefit from improved productivity and profitability by minimizing errors and reducing time to result, as well as brand protection and safer and healthier consumer products.

And Lori Daane Pharma Microbiology Scientific Director at bioMérieux

Lori Daane is the Director of Scientific Affairs at bioMérieux and has experience in clinical, environmental and industrial microbiology.  She is a technical expert on Rapid and Alternative Methods and participates in the sourcing and evaluation of new technologies and potential partnerships in the field of microbial control.  She provides scientific support to the Healthcare Business in North America and is responsible for managing feasibility testing and method development for bioMérieux instruments and culture media products.  Lori received her Ph.D. from the University of Minnesota in Microbial Ecology.  She also holds a Master’s degree in Limnology from the U of MN and a Bachelor’s degree in Medical Technology from Ferris State University.

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