Lonza and Sanofi entered into a strategic partnership in 2017, establishing BioAtrium AG to build and operate a mammalian cell culture facility for monoclonal antibody production in Visp (CH). The large-scale facility utilizes 20,000 liters bioreactors.
Bacthera is a strategic joint venture (JV) which was established by Lonza and Chr. Hansen (now Novonesis) in 2019. The company is now a specialized CDMO dedicated to the Live Biotherapeutic Product (LBP) industry. Since 2020, it has offered drug substance and drug product development services for customers developing LBPs.
Bacthera’s sites in Hørsholm (DK) and Basel (CH) both received manufacturing and GMP licenses from their respective national health authorities in May 2021, to supply customers with LBP medications for human clinical trials and ultimately develop commercial products. In 2023, Bacthera acquired a GMP certified, microbial drug substance manufacturing facility in Léon (ES). This acquisition increases manufacturing capacity for LBPs with bioreactors of various sizes up to 3,500 liters and allows Bacthera to offer a more complete end-to-end solution to the entire LBP market.
In November 2021, Bacthera announced a collaboration with Seres Therapeutics, a leading microbiome therapeutics company, to manufacture VOWST (fecal microbiota spores, live-brpk; formerly known as SER-109). VOWST was approved by the FDA in 2023 and is the first and only FDA-approved orally administered microbiota-based therapeutic indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).
Moving forward, Bacthera will continue to expand its offering, including larger cGMP batch sizes for Phase 3 and commercial production. The company’s ambition is to cover the entire drug substance and drug product supply chain for LBPs in an integrated offering.
As part of the Seres Therapeutics collaboration, a new Microbiome Center of Excellence has been built at our Ibex® Solutions campus in Visp (CH). With this new facility, Bacthera will offer fully integrated end-to-end live biotherapeutic development, clinical trial material manufacturing and commercial manufacturing services.
