How to define superior quality standards for probiotics

In recent years, probiotics have become highly popular with consumers¹. As global demand for probiotic products increases, consumers are looking for evidence-backed, high-quality products when making purchasing decisions². Unfortunately, a historical lack of manufacturing standards and emphasis on scientific rigor has made it difficult to separate effective probiotics from products lacking clinical merit. As a result, contemporary markets are flooded with thousands of new probiotic products with a wide range of claimed clinical applications and little supporting evidence.

In this review, the authors consider a wide range of mechanisms of action by which probiotic microorganisms can confer their functional (i.e., biochemical and physiological) effects, with an emphasis on dietary applications. They assess the capability of modern, highly sophisticated in vitro and ex vivo assay techniques to better analyze the effect and safety of specific bacterial strains, allowing for highly-targeted, evidence-based formulation development³.

Crucially, the review describes key manufacturing and safety aspects that should be addressed by product developers aiming to deliver both clinical efficacy and reliable, quality products. Specifically, they identify viability throughout shelf life (i.e., stability), gastrointestinal survival, metabolic activity, product quality, composition validation and safety monitoring as key areas that help validate a product’s end quality.

Ultimately, it is asserted that to develop effective, safe, high-quality formulations, manufacturers must use these emergent methodologies to screen multiple strains and select only strains that show relevant functional properties and that can be considered safe for human consumption3. The authors also note the importance of ongoing, post-market efficacy studies to further bridge the gap between clinical observations and real-world results.

“With probiotics gaining more and more awareness and popularity around the world, it is more important than ever to partner with companies that lead the way in both research and quality,” said Coline Gerritsen, Director Research & Development at Winclove Probiotics. “We are proud to acknowledge our ongoing role in raising quality standards in the probiotics industry. We firmly believe that the probiotics industry should be defined by scientific and product excellence, similar to our colleagues in the broader life sciences space, and we are excited to be leading the charge.”

“Institut Allergosan is a synonyme in all the German speaking countries for medically relevant probiotics of highest quality,” says Anita Frauwallner, founder and owner of this competence centre for Microbiota research in Graz. “Therefore it has been a great honour that the peer reviewed journal nutrients has asked our scientific team together with Winclove´s specialists for an article which defines the most relevant quality criteria that have enabled our evidence based probiotics to show a significant impact on gut barrier, inflammation and immunologic factors in patients as well as in healthy humans.”

Read the manuscript ‘The Development of High-quality Multispecies Probiotic Formulations: from Bench to Market’

References:

1. https://www.businesswire.com/news/home/20190821005461/en/Global-Probiotics-Market-Surpass-77-Billion-2025
2. IPA NMI solutions reports, USA, EU, APAC 2019 (www.internationalprobiotics.org)
3. a. b. Grumet L, Tromp Y, Stiegelbauer V. The Development of High-quality Multispecies Probiotic Formulations: from Bench to Market. Nutrients 2020, 12(8), 2453; https://doi.org/10.3390/nu12082453