The market for probiotics and live biotherapeutics continues to grow, as consumers and manufacturers increase their understanding of how they can improve health. Within this market, ‘next-generation probiotics’ offer significant potential: as they are naturally part of the normal human microbiota, they are much more likely to successfully colonise the recipient or be metabolically active.
However, growing these living, strict anaerobic organisms for clinical trials or future commercialisation takes special knowledge, skills and equipment.
At NIZO, we have successfully carried out more than 50 productions of strict anaerobes, including optimising and upscaling production of several next generation probiotics. We combine this proven expertise with our science-driven models and methods, and our in-house laboratory facilities.
In our food-grade pilot plant, we can produce next-generation probiotics with the stability, yield and quality needed for human clinical trials. If you are developing a pharmaceutical application (life biotherapeutic product manufacturing), we can align upscaling with good manufacturing practices (GMP) requirements and prepare the tech transfer to a pharmaceuticals contract manufacturing organisation (CMO).
Using our strict anaerobic production expertise, we have developed an approach that has successfully supported clients in cultivating next-generation probiotics. For one client, Caelus Health, this involved optimising production of the strict anaerobe, Anaerobutyricum soehngenii1.
Caelus Health is developing an entirely new class of Microbiome Therapeutics aimed at reducing insulin resistance and preventing Type 2 diabetes in people with metabolic syndrome. They are developing an oral formulation using Anaerobutyricum soehngenii. To carry out the clinical trials, they needed sufficient volumes of bacteria.
By optimising the culturing media and production parameters upstream, NIZO succeeded in increasing biomass density 3-fold, using industrially applicable media. We then improved the formulation and downstream production process and achieved a 20-fold increase in bacteria survival. Finally, we ensured the product stability needed for successful commercial production.
With this approach, NIZO achieved the bacteria yields needed for the envisioned clinical trial. We followed this same approach for the successful production of over 50 next generation probiotic strains, delivering these to customers in frozen or lyophilised format, for more clinical trials.
Cases like this reflect how important it is to consider both upstream and downstream process optimisations when upscaling the production of next generation probiotics. It’s clear that bringing products with living organisms such as probiotics and microbiome therapeutics to market involves many challenges, and that NIZO’s robust, scientific- and knowledge-based approach can help companies advance in a stepwise manner throughout the development journey.