Natural Products Insider

MAR-APR 2018

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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20 INSIDER March/April 2018 Over the last decade, probiotics have taken the market by storm. In this rapid rise of products hitting the market, brands often scramble to ensure their products are manufactured to the highest quality. Unfortunately, many companies looking at probiotics as a marketing opportunity don't understand the challenges associated with probiotic ingredients. While they are commonly referred to as "good bacteria," the high microbiological counts of probiotics can contaminate surfaces and air quality of manufacturing or testing lab environments. These facilities are usually bacteria-free areas, and introducing probiotics brings a risk for contamination to the other clean, low-bacteria products. Additionally, many probiotic ingredients need to be stored under refrigerated conditions and have specifi c handling requirements. For these reasons, choosing manufacturers and testing labs specially designed to handle these types of ingredients is extremely important. Qualifying vendors will ensure brands select partners knowledgeable about probiotic products and focused on quality. When choosing a vendor, brands can follow routine quality steps that can be verifi ed by asking specifi c questions. This will help a brand choose a manufacturer that has a quality management system (QMS) in place. The qualifi cation should also include questions regarding its adherence to FDA guidelines for dietary supplements. Following the Code of Federal Regulations (CFR), manufacturers should adhere to all aspects of the quality manufacturing process including personnel, facilities, record keeping, specifi cations, testing, labeling and more. Brands should also consider a manufacturing partner that has a facility designed for probiotic ingredients. This will help ensure the brand is working with a partner that can produce a quality probiotic product. Before developing a new probiotic formulation, brands must contemplate many factors and decisions. Formulating with ingredients that will provide the health benefi ts and desired stability requires research and expertise. Ingredient suppliers will have valuable information about the shelf life of their probiotic ingredients and may also have an on-site formulation department that can help brands navigate and streamline the complex process of developing and manufacturing probiotic products. Choosing a testing lab is also a priority for ensuring a quality probiotic product. No two testing labs are the same, and they often have specialties in the methods they perform. For a microbiology lab to perform probiotic testing, planning and thought need to go into the sample fl ow of the microbiology space to avoid cross- contamination; not all labs are able to perform probiotic methods. Even in-house labs may choose to outsource microbiology assays due to air-quality concerns, use of specialized equipment, multiple dilutions, anaerobic chamber incubation and other necessary requirements. Following GMPs (good manufacturing practices), testing starts with raw material potency, ingredient identity and adulteration examination. Blends and fi nished products should also be tested to ensure they meet label claims. The identity and assay methods for blended probiotic strains are usually challenging. Genetic testing is used to confi rm identity, and these methods are still being perfected for multi-strain blends. To measure potency, the enumeration is measured in colony-forming units (CFU/g), and this testing is performed as one assay for the entire blend. Since each probiotic strain may have a different medium it grows best on, it often takes method development to determine the best testing for obtaining the CFU/g count for a blend. Working with a lab experienced with these specialty ingredients can help mitigate challenges to ensure successful testing results. Stability testing needs to be completed if the label will include an expiration or "best by" date. Stability testing will give needed data to conclusively establish this date. This testing can be a long, expensive and complex undertaking. Raw material supplier recommendations need to be taken into consideration when planning the stability study. Real-time studies enable brands to set accurate dates for labeling. Many companies want to perform accelerated studies to have labeling information in a short time frame, but generally, an accelerated stability study may show a rapid decline in shelf life in comparison to the real-time storage of the probiotic product. This makes it diffi cult to use the accelerated study information for setting the date on the label; however, this may still be required for some international registration bodies. Deciding on ideal storage conditions, time intervals and logistics for probiotic products can be overwhelming. Many freeze-dried strains will have their own recommendations for cold storage or refrigeration to ensure the best shelf life. Spore-forming, enteric-coated, lipoic- coated or other specialty probiotics may provide options for room-temperature storage. The International Conference on Harmonization (ICH) is a good resource for determining the chamber storage conditions to set. Refrigerated, long-term conditions are recommended at 5 degrees Celsius ± 3 degrees Celsius, and general ambient conditions for long-term storage would be 25 degrees Celsius ± 2 degrees Celsius/60 percent relative humidity (RH) ± 5 percent RH. Clearly, probiotics have unique challenges compared to traditional supplement ingredients. Selecting fundamental partners with the right qualifi cations to help navigate the process is a worthy investment that will pay off in the long run. Tammy Blakemore is general manager at SORA Labs (, a third-party dietary supplement testing lab that specializes in enzyme testing. Developing Probiotic Testing and Manufacturing Partnerships by Tammy Blakemore Supplements: Probiotics

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