Case Study: Enumerating Probiotics in a Complex Herbal Supplement
Author: Andrzej Benkowski of Eurofins Microbiology Laboratories, Inc. (Madison, WI)
The Challenge
A probiotic co-manufacturer has made a finished product supplement containing a number of herbal ingredients combined with a blend of probiotics known to show favorable stability with the other actives present in the formulation. Upon testing the material for probiotic potency using the applicable manufacturer method, the results tested well below the specification and nowhere near the target input for the probiotic blend.
Our Approach
The client worked directly with our experts to troubleshoot the low result they were receiving. We first tried running the sample by flow cytometry to evaluate the viability of the organisms and show if they are present and viable in the matrix. This led to the hypothesis that there may be a step in the enumeration method causing rapid degradation of the material during testing. We further analyzed the method at a number of steps known to pose problems with recovery in certain situations.
The Solution
Upon reviewing the steps of the method, our microbiologists determined the pH of the initial dilution dropped below the threshold for bacterial survival upon rehydration. This drop in pH in conjunction with a prescribed hold time of the method was believed to be causing the lack of recovery. Two method modifications were applied - removing the hold time and adjusting the initial dilution step from a 1 to 10 to a 1 to 100. Upon re-testing the sample with the modifications, the test demonstrated good recovery right at the target potency of the formulation.
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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