The Development of High-Quality Multispecies Probiotic Formulations: From Bench to Market

Abstract

Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. To date, there is an increasing number of commercially available products containing probiotics on the market. Probiotics have been recommended by health care professionals for reasons ranging from their long-term immunomodulatory effects to proven benefits in the management of different health conditions. For probiotic products, there are several important aspects that determine the success rate of the development from bench to market. The aim of this review is to explore how the current knowledge on microbe-microbe and host-microbe interactions can be used to develop high-quality, evidence-based probiotic formulations, specifically probiotic dietary supplements, with a focus on the selection of safe strains with relevant functional properties. In addition, we will highlight aspects of the probiotic manufacturing process that need to be considered during the product development and the subsequent manufacturing process to guarantee consistent efficacy of a probiotic product. For each high-quality probiotic formulation, it is important to screen multiple strains, and select only those strains that show relevant functional properties and that can be considered safe for human consumption. In addition, it is imperative that attention is paid to the product development and manufacturing process, and that safety and quality properties are monitored. Importantly, the beneficial effects of probiotics should be evaluated in product efficacy studies and post-marketing surveys in order to demonstrate their clinical efficacy. All these aspects need to be evaluated and validated during the development of a successful high-quality and ready-to-market probiotic.

Keywords: clinical evidence; multispecies; probiotics; quality criteria; safety aspects.

Figure 1

Schematic overview of the multidisciplinary approach that is needed for the development of an evidence-based, indication-specific, multispecies and ready-to-market probiotic. All the steps needed for strain and product development are shaped by the functional, regulatory and quality requirements of the final product. During this process, several candidates (of strains, additives, production process blueprints, and packaging ideas) get discarded. In addition, manufacturing processes are finetuned and analytical methods need to be developed to guarantee consistent efficacy and safety of a finished probiotic product. Strain and product development is followed by product efficacy studies and post-marketing surveys in order to demonstrate clinical efficacy of the finished probiotic product.