Rapid Microbiology Applications in the COVID-19 Era

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.
 
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 (http://microbiologyconsultants.com) and owner of http://rapidmicromethods.com, 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 remediation, 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.
Followed by
Ulrich Herber Director of Technology and Market Development Charles River

After receiving his Doctorate Degree in organometallic chemistry from the University of Wuerzburg, Dr Ulrich Herber started his career in the pharmaceutical industry at Sartorius as a Product Manager for sterile filtration process validations. He then moved to Concept Heidelberg where he was the Operations Director for their business segment “Microbiological Quality Control and Biotechnology”. Later on, Dr Herber headed the European activities of Accugenix.
In his current role at Charles River, he is the Director of Technology and Market Development for the Microbial Solutions division. Dr Herber is co-author of scientific papers on new methods applied in microbiological quality control. He has held several talks covering recent developments in the area of rapid microbiological methods and is an Advisory Board Member of the Pharmaceutical Microbiology Working Group at the European Compliance Academy.
Followed by
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 provides scientific support to the Healthcare Business in North America.  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.
 
Sponsored by Charles River Laboratories and BioMérieux 

 
About Charles River Laboratories 
For 30 years, Charles River has been dedicated to the development of precise, robust micro QC solutions that help bring your products to market safely and efficiently. Our mission is to provide industry-leading scientific and technological advances that not only meet ever-changing regulatory guidelines but set a new standard in the way you perform testing. We’ve purposely built our portfolio to bring you progressive products and services that deliver accurate, relevant and measurable data to fuel confident decisions on product quality for release. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identification and strain typing keeps your manufacturing operations running efficiently and smoothly, lowers your cost to manufacture and protects your reputation.
About BioMérieux
A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux is present in 44 countries and serves more than 160 countries with the support of a large network of distributors. bioMérieux provides diagnostic solutions (systems, reagents, software and services) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are used for diagnosing infectious diseases and for detecting microorganisms in agri-food, pharmaceutical and cosmetic products. BioMérieux provides a portfolio of solutions that enable rapid and confident results to improve productivity and patient safety.