The microbiome is increasingly under exploration as a potential target for new therapies. Live biotherapeutic products (LBP) that influence mucosal or skin microbial ecosystems are being explored for diseases that are increasing in prevalence, such as obesity, cancer and diabetes. Biopharma companies are pursuing various strategies for modifying the microbiome, aiming to either restore specific microbial populations missing in disease, remove harmful ones or introduce genetically engineered strains.
There are currently no commercially available LBP. However, in 2020, there has been significant progress in the industry development pipeline with promising clinical results, combined with significant fundraising activity. As clinical development programs move towards regulatory approval, the demand for commercial manufacturing is expected to grow significantly in the coming years. Many companies developing LBP are smaller biotech or academic spin-offs who may not want to build up in-house manufacturing resources. These companies are looking for development and manufacturing partners who can scale production of strict anaerobes, provide specific drug delivery options and help navigate an emerging regulatory landscape.
In 2019, a 50/50 strategic joint venture (JV) was established between Lonza and Chr. Hansen for the development and manufacturing of LBP for pharma and biotech customers. The JV was approved to start operating under the name BacThera.
Since the beginning of 2020, BacThera has offered drug substance and drug product development services for customers developing LBP. The organization has grown to more than 70 employees (34% located in Switzerland and 66% in Denmark) and has already been successful in winning non-cGMP projects from North America, Europe and APAC. Customer project delivery is progressing according to plan, with encouraging results and excellent customer feedback.
The current manufacturing footprint is focused in Denmark and Switzerland. At the beginning of 2021, BacThera finalized the set-up of its cGMP drug substance facility in Hørsholm (DK), and the cGMP drug product facility in Basel (CH), with cGMP certification to take place in H1 2021.
Over the next few years, BacThera aims to expand its offering to larger cGMP batch sizes for Phase 3 and commercial production, with the goal of having drug substance and drug product supply chain available under one roof.