5 Things You Need to Know About Probiotic Enumeration Methods and How We Can Help
The highest quality probiotic products meet or exceed their label claim at the end of shelf life. Selecting the correct enumeration method is crucial to guarantee product integrity and potency. If the test method does not recover all of the probiotic organisms present in the product, there is a high probability it could test below the specification even if the material contains the correct amount of beneficial bacteria. Selecting an inappropriate enumeration method can lead to delays in production, disputes with suppliers, and headaches for all those involved. Here are five things you need to know about selecting the correct enumeration method and how we can help:
1. Manufacturer Methods are King
Your bulk probiotic raw materials comes with a Certificate of Analysis (COA) stating the amount of Colony Forming Units (CFUs) present for that particular lot. The strain manufacturer or co-manufacturer generates this result most often by using an enumeration method developed and validated by their internal quality control laboratory. These companies have put in the work to come up with methods to maximize the recovery of their strains for obvious reasons. To verify potency of the raw material by a third party testing lab such as Eurofins, comparing apples to apples by requesting the same method is key.
2. A Complex Probiotic Blend May Require an Alternative Method
The demands of the health-conscious consumer has led to companies incorporating more and more strains into their products. So which method do you choose when your formulation contains strains from multiple manufacturers? This is where standardized methods or internally developed methods come into play. Depending on where you are in the supply chain, the customer may dictate which method to follow or it may be a matter of trying a few different methods to determine which one works best for your particular product.
3. Other Active Ingredients in the Formulation May Pose an Issue with Recovery
In this situation, you blend the probiotic strains from a certain manufacturer with other active ingredients, run the correct manufacturer method and do not yield the correct number based on the theoretical target. Some ingredients simply do not allow the probiotics to remain viable in the product. Others may remain stable in the original format, but quickly degrade during the testing procedure. These are two very distinct concerns that require different solutions.
4. Sometimes, You Will Need to Develop Your Own Enumeration Method
Whether it be for a specific matrix, or a line of products with certain requirements during testing because of the format or formula, there may be a good cause to develop your own enumeration method.
5. Probiotic Enumeration Methods Differ from Standard Contaminant Microbiology
While probiotic enumerations are often lumped in with general microbiology testing since we are dealing with bacteria, they in fact require a different skill-set for execution and have an additional layer of complexity due to the sheer number of methods at the industry’s disposal. Enumeration methods are similar to that of an analytical chemistry test in that you are attempting to hit a target number of an analyte instead of confirming the absence of a harmful pathogen. These tests require an additional level of accuracy and precision in order to minimize the amount of measurement uncertainty that can come with these sorts of estimations. Here at the Probiotic Center of Excellence, we live and breathe probiotic enumeration methods and understand what is needed in order to produce the highest quality data. We understand what is at stake and can be a trusted partner when issues arise or things do not go as planned.
Customized Solutions with Eurofins
Manufacturer Methods
We are fluent in all of the major probiotic manufacturers’ enumeration methods. Our dedicated probiotic enumeration microbiologists are trained to perform these methods according to the manufacturer’s specifications. Eurofins routinely performs side-by-side evaluations with strain manufacturers to demonstrate our competency in running their methods. You can count on our laboratory to execute the method the exact same way as the manufacturer’s QC laboratory in order to match the values that come on the COA.
Probiotic Blends
Organizations such as International Organization for Standardization (ISO) and the United States Pharmacopeia (USP) have validated probiotic enumeration methods available. The country where you are selling the product may have a specific method you are required to follow as well. We offer a suite of internally developed and validated probiotic enumeration methods. Check out how our team supported a customer with a case study here!
Formulas with Active Ingredients
Our Probiotic Center of Excellence in Madison, WI has renowned experience and knowledge when it comes to problem-solving issues with recovery in products with both probiotics and active ingredients. We can customize methods to minimize degradation and maximize recovery of your finished format as well as consult you about formulation issues that may lead to increased degradation of your product. We also have additional tools such as flow cytometry at our disposal to help assess viability and integrity of the formulation by looking at the ratio of live, dead and injured cells. Check out how our team supported a customer with a case study here!
Develop Your Own Method
Our team is also well adept at method development and method validation studies for probiotic enumerations. We can customize these projects to fit your need and your budget and have the ability to expedite them when speed is a requirement. In the end, you will have your very own validated enumeration method tailored to your product(s) and a partner laboratory skilled in executing the method right from the get-go. Check out how our team supported a customer with a case study here!
Standard Contaminant Microbiology is Different
We are proud of our one-of-a-kind Testing Partners Program where we actively work with over 10 different probiotic suppliers to become qualified to run their strain-specific enumeration procedures and offer them to our joint customers. We routinely meet with probiotic suppliers to review updates to methodology and ensure alignment between labs. This extra step allows us to provide you with the premier enumeration service in the industry.
Reach out to us to learn more on how we can partner with your team!
