Novel production technologies for next generation microbial pharmaceutical products

Purpose and goal

The aim of this project was to develop novel technologies for production and formulation of next generation microbial pharmaceutical products, based on human gut commensal bacteria. This is needed, in order to bring recent science forward to achieve commercial products for improved health. Through the project, we have developed and implemented important technologies which may be used in production processes involving anaerobic gut bacteria.

Expected results and effects

In summary, the project has achieved the following: 1. Product strain viability over three months 2. Strain specific ID-method developed. The method works for strain detection in human, fecal samples. 3. Clinical safety trial performed with our product. Primary endpoint is achieved. 4. Novel formulation developed, completely stable in freezer. It is under assessment over time and in different environments. We are in a good position to reach the goal of 24 months stability in RT. 5. The proprietary production technology is deemed to be general and may thus be applied to other strains.

Planned approach and implementation

Based on know-how from our pilot strains, we have developed and tested technologies under the 5 WPs. The Project team has worked focused together to achieve our common goals and we have very efficiently been able to combine microbiome science, product development and the clinical assessment throughout the project period. We have kept a close dialogue within the team and the work flow that was implemented at the start of the project proved very functional. This resulted in good synchronization of the various activities so that we eventually reached our project goals.