Abstract
In a rapidly growing global probiotic market, end-users have difficulty distinguishing between high quality and poor quality products. This ambiguity threatens the trust consumers and healthcare providers have in probiotic products. To address this problem, we recommend that companies undergo third-party evaluations to certify probiotic quality and label accuracy. In order to communicate about product quality to end-users, indication of certification on product labels is helpful, although not all manufacturers choose to use this approach. Herein we discuss: third-party certification, the process of setting standards for identity, purity, and quantification of probiotics; some emerging methodologies useful for quality assessment; and some technical challenges unique to managing quality of live microbial products. This review provides insights of an Expert Panel engaged in this process and aims to update the reader on relevant current scientific methodologies. Establishing validated methodologies for all aspects of quality assessment is an essential component of this process and can be facilitated by established organizations, such as United States Pharmacopeia. Emerging methodologies including whole genome sequencing and flow cytometry are poised to play important roles in these processes.
Highlights
Probiotics are being actively researched as agents to enhance health and mitigate disease
Health benefits of probiotics have been studied in controlled human trials, which document a diversity of benefits (Sanders et al, 2018)
The total global retail market for all probiotic products was estimated at ∼$45.6 billion U.S for the year 2017, with a predicted compound annual growth rate of 7% (2017–2022) (MarketsandMarkets, 2017)
Summary
Probiotics are being actively researched as agents to enhance health and mitigate disease. The authors developed a FC protocol combining these specific antibodies and membrane integritybased viability assessment (International Standards Organisation [ISO] and International Dairy Federation, 2015) This protocol was successfully applied on commercial products containing blended probiotic strains allowing specific quantification of each strain as well as distinction of the viable and non-viable microbial populations (Chiron et al, 2018). These protocols delivered results in a very short time (48 h), bringing efficient tools for research and development and quality control. Based on low occurrence rates in probiotic ingredients and products, the EP did not include Listeria monocytogenes, Staphylococcus aureus, or Pseudomonas aeruginosa as specified
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