PDA Letter Article

Success Stories: RMM Implementation in the 21st Century

by Michael J. Miller, PhD

The implementation of rapid methods is moving at a record pace. The development of next-generation advanced therapy medicinal products and novel treatments and vaccines, including those targeting COVID-19, requires faster microbiology solutions to meet the current needs of the worldwide patient population.

This year, PDA will bring the latest advances in rapid microbiology technologies, case studies, applications and regulatory guidance directly to your computers and smart devices. The line-up for our 2020 virtual workshop is certain to provide a long-lasting benefit to participants. As with last year’s very successful workshop, the Rapid Microbiological Methods (RMM) Workshop, Oct. 22-23, will immediately follow the 15th Annual PDA Global Conference on Pharmaceutical Microbiology.

First, Erika A. Pfeiler, PhD, Supervisory Microbiologist, CDER, U.S. FDA, will moderate a panel discussing case studies on method suitability and validation. Here, you will learn about the evolution of an automated rapid microbial testing technology for industrial applications and the validation and global implementation of an alternative sterility test.

Next, you will hear from industry specialists and regulators about how to overcome some of the challenges associated with rapid testing, including the need to implement very fast microbiological methods to support sterile compounded medicines. Moderator Andrew D. Hopkins, Director, Operation Quality QA Audit and Compliance, AbbVie, Inc., will introduce presenters discussing sampling and rapid sterility tests and how to address out-of-trend or aberrant results. There will also be an opportunity to hear firsthand from regulators some of the issues they see when companies introduce rapid technology.

Friday morning starts with a panel, led by Michael J. Miller, PhD, President, Microbiology Consultants, LLC., and Co-chair of the RMM Workshop program committee, exploring recently developed rapid methods. These include the use of Raman-based chemometrics for quality release, a miniaturized and automated PCR-based system for the rapid detection of Mycoplasma and the validation of an enrichment-free ATP technology.

The workshop will conclude with the always popular “Ask the Experts and Regulators” session, where you can pose your questions to our distinguished panel and take advantage of their experience and perspectives to help guide your decision-making processes.

My co-chair, Amy McDaniel, and the entire program committee (Erika Pfeiler, Lisa Wysocki, Irving Ford, Sven Deutschmann and Andrew Hopkins) encourage you to participate in this year’s workshop to expand your knowledge on the most up-to-date and cutting-edge applications for rapid microbiology.

About the Author

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