"Implementation of Rapid Microbiological Methods will play a vital role in contributing to the Global Health for drugs"

The inaugural BioLuminescence 2025 event by Merck took place in Ahmedabad on February 20, serving as a pivotal platform to enhance engagement with regulatory bodies, key opinion leaders, and stakeholders in the pharmaceutical industry.

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Dr Michael Miller, President, Microbiology Consultants, LLC

An internationally recognised microbiologist and subject matter expert in pharmaceutical microbiology, contamination control, Dr Michael Miller, President - Microbiology Consultants, LLC spoke about the Future of Pharma QC and how Rapid Microbiological Method (RMM) play a key role there.

What are some of the developments you have seen in quality control (QC) Microbiology from the past 10 years, some trends that stood out for you in this space?

There are a number of startups that have been pushing the envelope in microbial detection, quantification and identification and newer technologies that are miniaturised, such as lab-on-a-chip platforms, and real-time detection of microorganisms. I expect to see this trend continue in the foreseeable future.

What are the latest RMM technologies being developed to support pharmaceutical companies?

The science of biofluorescent particle counters (BFPC) has been around for a number of years. However, sterile pharma manufacturers are now validating these for routine use. They produce an autofluorescent unit (AFU) in real-time, allowing manufacturers to immediately react to excursions or out-of-trend findings for viable microorganisms, rather than retrospectively addressing these issues once incubation on standard plates have completed, which could be as long as a week since the batch was manufactured. And many of these systems are designed to capture the sampled air flow onto conventional media in the hopes of growing these for subsequent studies, such as microbial identification, which may help with investigations associated with the original contamination event. I also manage a catalogue of existing and next generation RMMs that is constantly changing as new technologies are introduced.