Alternative and rapid microbiological methods (ARMMs) can detect and enumerate microbiological contamination. Their use is encouraged by regulatory authorities, but until relatively recently, there has been a lack of focused industry effort to promote their adoption.
This is why, in 2017, BioPhorum formed an ARMM team to support the implementation of these rapid microbiological methodologies. It consists of three independent teams – covering Automated Colony Counters, Rapid Sterility Test Methods, and Bio-Fluorescent Particle Counters (BFPC) – and has made great progress in raising the profile of these technologies.
BFPCs in particular have proved a challenging topic as it requires a completely different approach compared to the traditional method. Therefore, in 2020 the BFPC team looked for ways to improve its impact in promoting this new technology and for allies to further influence regulators and increase industry knowledge.
The answer was to form the Modern Micro Methods Collaboration (M3) in 2021. It consists of four groups:
- BioPhorum’s BFPC team
- the Kilmer Community Rapid Microbiology Methods group
- the Process and Environmental Monitoring Methods (PEMM) working group
- and the Online Water Bioburden Analyzer (OWBA) working group.
Since 2021 these working groups have been forging a collaborative path to support industry adoption and use of modern microbial methods, concentrating on the adoption of bio-fluorescent particle counters. The many benefits from the Collaboration include pooling the knowledge of all groups, accessing a wider network of contacts in regulatory and advisory bodies, increasing the number of deliverables, and creating challenging and lively discussions – all leading to better-informed work for each group and the Collaboration overall.
The Collaboration consists of a steering committee and three sub-teams:
- sub-team 1 produces articles that address challenges to implementing BFPC systems identified at the first M3 summit in early 2021
- sub-team 2 focuses on understanding baseline counts and methods for establishing action and alert limits for BFPC systems
- sub-team 3 creates templates and publications to support internal communication and the implementation of modern microbial methods.
The M3 Collaboration has been working on various articles. So far, it has published an Initial evaluation roadmap for modern microbial methods (Parenteral Drug Association (PDA) Letter) and an article on Challenges encountered in the implementation of BFPC systems as a routine microbial monitoring tool (PDA Journal of Pharmaceutical Science and Technology (JPST)).
An article on Understanding the non-equivalency of BFPCs versus the colony-forming unit will soon be published in the PDA JPST, as will be an opinion piece on Why the regulatory expectation for microbial identifications in Grade A when using a non-growth-based monitoring method should be re-visited (PDA Letter). A series of additional articles, webinars, and podcasts are in progress.
“It is inspirational and motivating to work within such a committed and experienced group of industry experts,” said Petra Merker, Biological Quality Control Expert at Bayer AG. “Together, we will be able to move forward with Bio-Fluorescent Particle Counting.”
Since its start, the M3 Collaboration has organized three summits with keynote presentations by industry-leading experts on the Application of USP<1223> to the Validation of Biofluorescent Particle Monitoring (BFPM) (2021), Water Based BFPC Test Case Overview and USP Pharm: Waters Expert Panel Current Work (2022), and Novo Nordisk’s Path to BFPC Implementation: Navigating the Maze of Regulatory Expectations (2023). The Collaboration also delivered presentations throughout 2022 at conferences organized by the Kilmer Community, ISPE, the PDA, and others.
Looking ahead, the M3 Collaboration will continue focusing on communications with its LinkedIn page, webinars and podcasts that follow each new publication, and a dedicated M3 website. There will also be in-person meetings at industry events, continued discussions with industry working groups, and engagement with regulators. In addition, it will continue to publish and promote its papers and lay the scientific foundations for implementing and using BFPCs and other ARMMs.
The M3 Collaboration is a great demonstration of the essence of BioPhorum – that collaboration is crucial to our collective success.
Are you interested in modern microbial methods? Would you like to collaborate with an amazing group of experts as they work to support the use of modern microbial methods within the industry?
If so, please contact Margit Franz‑Riethdorf, Global Change Facilitator, on firstname.lastname@example.org