Use of Rapid Microbiological Methods

Comparing Rapid Microbiological Method Usage in the Food and Pharmaceutical Industries

I followed with interest Dr. Michael Miller’s blog from the PDA’s 6th Annual Global Conference on Pharmaceutical Microbiology last week. Dr. Miller consults on regulatory, quality and compliance solutions for rapid microbiological methods (RMM) in the pharmaceutical, biotech, and medical device industries, and was blogging on the meeting’s presentations related to rapid and alternative microbiological methods.

The meeting’s opening keynote was presented by Dr. Daniel Y. C. Fung, who is an expert in rapid methods for the food industry and an Industry Professor of Food and Science at Kansas State University. Dr. Fung’s presentation reviewed the last thirty years of global developments of rapid methods. Dr. Fung incorporated market data from SCI’s Industrial Microbiology Market Review, Third Edition (IMMR—3), on total micro tests conducted and total market size for food microbiology testing.

As reported in Miller’s blog: “Within the food processing sector, it was projected that more than 740 million micro tests were performed in 2008 by more than 40,000 food processing plants, and it is estimated that the worldwide market for micro testing is more than $2 billion. And the market for food microbiology testing continues to grow, year over year. For example, the rate of growth of micro testing from 2008 to 2010 was more than 6%.”

Miller goes on to report that, “The take home message from Dr. Fung’s keynote is that the number of microbiology assays associated with the monitoring of food will continue to increase, especially in light of recent contamination events, and that rapid technologies will play a very important role in protecting the world’s food supplies.

What is interesting to me in all of this is the comparison of rapid microbiological method use in the food versus pharmaceutical sectors. Millers says that, “When asked what the pharmaceutical industry can learn from the food industry (in terms of the adoption of rapid methods), Dr. Fung stated that the expectations for microbiological safety is much higher in the pharmaceutical industry than in the food industry, and that we can benefit greatly from the implementation of rapid methods. Interestingly, the food industry looks up to the pharma industry for guidance on excellence in microbiology testing.

Dr. Miller goes on to say that in his view, the pharmaceutical industry “has been extremely slow to adopt rapid methods for a number of reasons, and that the food industry is actually well ahead of where we are today.”

Strategic Consulting has been conducting market research and developing business strategies for industrial diagnostics companies for more than 15 years. In that time, we have followed the growth—or lack thereof—of rapid microbial methods in the six key segments in the industrial microbiology testing market: food, beverage, pharmaceutical, personal care products, environmental, and industrial process water.

Without question, the usage of rapid microbiological methods is not uniform across all segments. As would be expected, the needs/drivers of each segment vary greatly, which in turn influence testing requirements. Sample matrices and organisms to be tested also come into play.

RMM usage in food, beverage, pharma, pcp, environmental and process water

Rapid Microbiological Methods Usage by Sector

What’s surprising is that the pharmaceutical industry actually uses the least amount of RMMs (measured as a percentage of total tests) of all the industrial segments. As seen in this chart from IMMR—3, currently less than 2.5% of all pharma tests utilize a RMM. Given Dr. Fung’s comments that all hold pharma in the highest regard, one would think that more use of RMMs would be the case. Certainly progress is being made, with more RMM approvals happening monthly, but the segment has much to do to catch up to some other areas.

In SCI’s report, Pharma/PCP Micro, Second Edition, we summarize the thoughts and experiences with RMMs of 20 key opinion leaders in the pharmaceutical and personal care products industries. These interviews give real insight into the successes and issues regarding adoption and usage of newer methods, such as the difficulty and expense in validating RMMs, concerns about FDA support and acceptance, and of course, return on investment.

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