SER-109 has the potential to be the first-ever live biotherapeutic product (LBP) to be produced commercially; the collaboration with Seres Therapeutics is a critical milestone for Bacthera, a joint venture between a Lonza Group Affiliate and Chr. Hansen.
Bacthera, a specialized contract development and manufacturing organization (CDMO) founded in 2019 as a 50:50 Joint Venture of Chr. Hansen A/S and Lonza, and Seres Therapeutics, a leading microbiome therapeutics company, announced a collaboration to manufacture SER-109, Seres’ lead product candidate for recurrent Clostridioides difficile infection (rCDI).
SER-109 is consisting of a consortium of highly purified Firmicutes spores, which normally live in the healthy microbiome. This potentially first-in-class investigational microbiome-based therapeutic is designed to prevent further recurrences of CDI in patients with a history of multiple infections by modulating the disrupted microbiome to a state that resists C. difficile colonization and growth. The SER-109 manufacturing purification process is designed to remove unwanted microbes, thereby reducing the risk of pathogen transmission beyond donor screening alone. The US FDA has granted SER-109 Breakthrough Therapy designation and Orphan Drug designation for the treatment of rCDI. Under the terms of the agreement, Bacthera is establishing a dedicated facility for commercial manufacturing in its new Microbiome Center of Excellence, a manufacturing site dedicated to the production of LBPs located on Lonza’s Ibex® campus in Visp, Switzerland.
Commercial manufacturing capacities
The agreement between Bacthera and Seres Therapeutics aims to expand upon Seres’ initial commercial manufacturing supply chain. In addition to Seres’ existing manufacturing infrastructure, the collaboration with Bacthera will expand the commercial production capacities of SER-109 and provide supply support. SER-109 has the potential to be the first product within the entire live biotherapeutic industry to be produced commercially. To support the commercial manufacturing needs of SER-109 and other LBPs, Bacthera is establishing a new Microbiome Center of Excellence dedicated to LBP Manufacturing at Lonza’s site in Visp, Switzerland.
The new Microbiome Center of Excellence will be based on Lonza’s proven Ibex® Solutions concept for manufacturing, providing capacity for early commercial launches and production. The new Microbiome Center of Excellence will occupy an overall footprint of approximately 12’000 m2 with three manufacturing floors, including capacity for commercial production. One of the three manufacturing floors will be dedicated to the manufacturing of SER-109.
Under the terms of the agreement, Bacthera will provide GMP drug substance manufacturing and filling of the final drug product formulation into capsules. The capsules will leverage Lonza’s Capsugel® hypromellose (HPMC) plant-based capsule portfolio combined with encapsulation technologies that are scientifically designed to improve the stability of the product by ensuring protection from humidity, gastric acid, and other environmental factors.