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NOW: 2016 Science of Supplement Winter Issue

Phase 2

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NOW: Committed to Ensuring the Highest Quality Standard

Probiotics contained in food and dietary supplements have a long history of providing health benefits for the human body. Recent publications have extended these benefits to almost every system in the body from the widely published studies on the digestive and immune system to the nervous system, respiratory, cardiovascular and sports performance. The probiotic strain or strains used in each of these studies had unique properties responsible for the observed health benefit. Thus strain identity of each of these probiotic species has become very important in meeting consumer health needs. It is only through strain identification that probiotic species are differentiated between their health benefit or virulence factor. Therefore, strain identity is a critical part of the quality and safety of the product. The ability of the manufacturer to verify the identity of the probiotic strain is now becoming an important quality assurance step to ensure that strain information and potency is not lost during the manufacturing process.

For years, NOW has been testing and enumerating the potency of its probiotic products from raw material to finished product. The company also conducts stability testing to ensure that viable dosage claims are met throughout the shelf life at recommended storage conditions. Current standard identity testing involves selective culturing, biochemical and serological typing. While most probiotics manufacturers depend on their probiotic culture manufacturer’s certificate of analysis to identify and enumerate the probiotic they are supplying, NOW added to its state-of-the art testing facility the ability to perform genetic identity testing to verify the identity of the bacterial strains beyond the genus and species of their probiotic products. As a finished product manufacturer, NOW has pioneered and developed a validated and robust genomic standards library of all the probiotic strains used in their probiotic products, with the collaboration of their culture suppliers, using the DuPont RiboPrinter Microbial Characterization System.

Strain Identity

The probiotic strains are identified by “fingerprinting” genomic DNA. This is a strain typing method commonly called “ribotyping.” The DuPont RiboPrinter Microbial Characterization System is used to automate the method and is a routine part of NOW’s batch-specific testing and quality control. The RiboPrinter tracks the integrity of strain information from raw material to final product manufacturing with genetic level accuracy and reproducibility. It has the ability to differentiate strains of the same genus and species and assures advanced maintenance and stability of the probiotic culture integrity. This same feature is also used to isolate, track, trend and investigate contamination. This technology has been a staple of cGMP (current good manufacturing practice) pharmaceutical manufacturing for decades and NOW extends the application for the genetic identification of all their probiotic strains. This investment further reinforces NOW’s commitment to ensure the highest quality standard of its products.

In the future, companies will need to provide greater data and substantiation that the strains in their probiotic products are as claimed on labels. FDA (U.S. Food and Drug Administration) requirements for strain identity of new dietary ingredients and supplier verification requires manufacturers to verify the culture identity of their probiotics especially for safety. Since health benefits for probiotics are strain specific, the identity of probiotic strains through genetics-based identification technology could become the new standard of quality to assure consumers that they are receiving the clinically validated strain for the label claim.

The biggest challenge in probiotic testing is the culture-independent identification and concentration verification of mixed strains. New technology that involves molecular methods based on polymerase chain reaction (PCR) identification and metagenomics are being developed to further enhance the accuracy and efficiency of the identification. NOW is actively participating in the development and validation of these future methods. These new probiotic testing methods along with RiboPrinter technology are being established to ensure the safety and efficacy of the probiotics for the consumer’s health benefit.

References:

Holzapfel WH, Habarer P, Geisen R, Bjorkroth J, Schillinger U. Taxonomy and Important Features of Probiotic Micoorganisms in Food and Nutrition. The American Journal of Clinical Nutrition 2001;73(suppl): 365S-73S.

Easy, Reliable and Fast Method Tracks Probiotic Strains of Lactobacillus with DNA Fingerprinting. Retrieved from www.dupont.com/products-and-services/food-protection/dupont-food-diagnostics/brands/riboprinter/articles/rp-ap-track-probiotic-strains.html.

Stahl, B. (2016, April). Probiotic Testing in the US: Now, Next and Future. Workshop presentation at the Workshop Series: Microbiology Testing for Herbal Products and Dietary Supplement Industries, College Park, MD.