Currently, fermentation is a commonly used method to manufacture commercial probiotic strains such as Lactobacillus spp. or Bifidobacterium spp. The advantage is that it can be easily scaled-up at relatively low cost, but the challenge is do it while respecting good manufacturing practices (GMP). When working to obtain cGMP certification, costs increase rapidly: in the case of manufacturing microbiome therapeutics, increased cost resolve around large batch fermenting vessels and anaerobic chambers for manipulation. This means that new strategies will have to be developed to enable large scale probiotic manufacturing.
Some of the systems being explored currently include disposable or low capital cost bioreactor designs, dynamically changing growth conditions and inoculation strategies reducing batch-to-batch variability as well as novel, low-cost media components. But companies in this space are realistic, and a number of challenges will need to be addressed. In July 2019, Informa polled 89 executives operating in the microbiome space. When asked what the biggest challenge they are facing specifically around manufacturing and scaling up, three issues dominated: the importance of viability, potency and purity was the biggest challenge for 30% of respondents, followed by creating new standards (25%) and limited choice of CDMOs for certain types of bacteria (20%).iii
