Case Study: When to Develop Your Own Probiotic Enumeration Methods
Author: Andrzej Benkowski of Eurofins Microbiology Laboratories, Inc. (Madison, WI)
The Challenge
A client was looking to launch a new probiotic gummy product formulated with Bacillus coagulans. When the gummy was tested for an enumeration of Bacillus coagulans following the prescribed method from the strain manufacturer, the results were much lower than anticipated based on the expected levels of spores added into the product during formulation. In addition, the customer was on a tight timeline and was not sure if they had time for method development.
Our Approach
Our team of experts worked with the client to troubleshoot a possible root cause for the decrease in recovery. It was determined during the out of specification investigation that the homogenization steps in the manufacturer’s method were not sufficient in getting the gummy matrix into solution. We took a two-step approach to aid in the dissolution applying a high-speed blend step followed by a sonication step in order to break up the microscopic clumps of Bacillus coagulans. Upon re-testing the sample with the modified homogenization steps, the recovery improved, but was still below the expected levels and outside the range of the test method variability. The technical team suggested trying a few different types of growth media and incubation conditions. This second study demonstrated there was better recovery when using an alternative growth media at a higher incubation temperature.
The Solution
After coming up with these modifications to improve recovery, we went ahead and validated the new customer-specific method tailored to the unique matrix and the client’s quality system. In addition, we were able to meet the deadline required by the client in order to release their new product to market on time. They now have their own validated enumeration method they can use going forward to test their gummy product for Bacillus coagulans potency.
Our Team
Eurofins Microbiology Laboratories, Inc. in Madison, WI is our Center of Excellence to support probiotics and has the necessary expertise and capabilities to individually evaluate each product and ensure we are preparing the samples for accurate identification, enumeration, or contamination. We actively work with probiotic suppliers to become qualified to run their strain-specific enumeration procedures and offer them to our joint customers.
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