The term “next generation probiotics” usually refers to commensal bacteria that are isolated from human niches such as the gut, skin or oral cavity. These probiotics are considered to have high potential as they are endogenous to the host and are therefore much more likely to colonize the host or be metabolically active in the relevant niches. However, commensal bacteria are in general strict anaerobes and due to their complex nutritional requirements they are much more difficult to culture, especially at a larger scale.
With more than 70 years of expertise, we have successfully optimized and up-scaled the production of several next generation probiotics. Strains with potential probiotic benefits, selected from healthy human gut and skin, have been produced in our food grade NIZO Processing Centre, delivering viable biomass for human clinical trials.
Clinical Trial Production
We have been approached by several customers to support them in the cultivation of next generation probiotics. One example of our work with clients is the project for Caelus Health. They are developing an entirely new class of Microbiome Therapeutics for the reduction of insulin resistance and prevention of Type 2 Diabetes (T2DM) in people with metabolic syndrome. We worked together to develop an oral formulation based on E. hallii to improve insulin sensitivity in people with Metabolic Syndrome and to reduce the chance to develop T2DM. To implement the optimal manufacturing process, we optimized media and developed a strict anaerobic production process, including packaging into portions suitable for clinical trials. The optimization of medium and production parameters turned out to be crucial for the successful industrial scale production, as shown by the up to 3-fold biomass density increases achieved in the newly defined food-grade media. The aforementioned process that was developed was used for the production of several probiotics that were subsequently supplied in frozen or lyophilized format for use in clinical trials by our customer.