PDA Letter Article

Real-World Applications of Rapid Micro Methods

by Tony Cundell, PhD, Microbiological Consulting, and Michael Miller, PhD, Microbiology Consultants

Though rapid microbial methods present the opportunity to conduct efficient testing across pharma, most manufacturers, whether due to method application or regulatory/compendial uncertainties, have yet to adopt them.

The 2019 PDA Rapid Microbiological Methods Workshop, held in Rockville, Md., following the 14th Annual PDA Global Conference on Pharmaceutical Microbiology, last Oct. 23–24, provided an opportunity for members of the industry to hear from global regulators and compendial representatives on the topic. The 130 attendees—including 11 who attended virtually via a live stream over the Web—learned from the case studies presented how some firms have successfully implemented rapid methods.

The workshop opened with a comprehensive discussion of U.S. FDA regulatory expectations from Erika Pfeiler, PhD, Supervisory Microbiologist, CDER, and Simleen Kaur, Biologist, CBER. Former MHRA Inspector Andrew Hopkins offered an EU perspective. A highlight of the session was a presentation by Haijing Hu, PhD, Senior Microbiologist, CDER, on the application of rapid microbial methods in sterile compounding.

The afternoon concluded with talks exploring chapters on rapid microbiological methods in the U.S., European and Japanese pharmacopeias. The organizers were fortunate to welcome Yutaka Kikuchi, PhD, Professor, Chiba Prefectural University of Health Science, who shared his experience with Japanese practices on rapid microbial method in the pharmaceutical sciences. Tony Cundell, PhD, Principal Consultant, Microbiological Consulting, and a member of the 2015–2020 USP Microbiology Committee of Experts, spoke from USP’s point of view while Sven M. Deutschmann, PhD, Head of Global Analytical Science & Technology, Roche Diagnostics, provided information on Ph. Eur. Chapter 5.1.6 “Alternative Methods for Control of Microbiological Quality.” Collectively, these talks underscored the varying levels of acceptance for rapid methods by global pharmacopeias provided certain conditions are met.

Day 2 of the workshop featured a number of case studies on rapid microbial methods, including real-world applications. Frederic Ayers, Research Scientist, Eli Lilly, looked at real-time feedback to control for biofluorescent particles. Andrew Finnerty, General Manager, Centre for Cell Manufacturing Ireland (CCMI) at NUI Galway, showed how to use rapid sterility testing on advanced therapy medicinal products. Here, a product is often injected directly into a single patient within a short time frame where traditional sterility tests are inadequate. Similarly, compounded pharmaceutical products can also be produced as individual batches. Anthony Grilli, MS, Owner, FOCUS Laboratories/Atlas Analytical, presented a case study on using a real-time rapid microbial detection solution for releasing a compounded product.

Other case studies addressed rapid mycoplasma testing, real-time PCR detection of Burkholderia cepacia and automated colony-counting.

The workshop closed with an “Ask the Experts and Regulators” panel that provoked a lively exchange between the audience and panel members James Kenney (FDA, CBER), Michael Miller, PhD, President Microbiology Consultants, Erika Pfeiler, Tony Cundell, Sven Deutschmann and Andrew Hopkins. The topics of discussion ranged from satisfying global regulatory requirements to parametric release to the impact of Brexit on testing requirements.

The presentations at the 2019 PDA Rapid Microbiological Methods Workshop were comprehensive, compelling and insightful. PDA will host a second workshop, the 2020 PDA Rapid Microbiological Methods Workshop, in October. The upcoming workshop will likely feature more in-depth discussion on rapid methods as the industry moves toward acceptance of these innovative methods.