Bacthera, a specialized contract development and manufacturing organization (CDMO), and Seres Therapeutics, a microbiome therapeutics company, formed a collaboration to manufacture SER-109, Seres’ lead product candidate for recurrent Clostridioides difficile infection (rCDI). 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.
 
CDI, causing severe diarrhea and colitis, an inflammation of the colon, has been classified as one of the greatest microbial threats to human health by the Centers for Disease Control and Prevention (CDC). It is the leading cause of hospital-acquired infections in the U.S. and is responsible for 170,000 hospitalizations and the deaths of more than 20,000 Americans each year. SER-109 is a potentially first-in-class investigational microbiome-based therapeutic consisting of bacterial spores from healthy human donors. This consortium of human microbiota from the gastrointestinal tract is designed to prevent further recurrences of C. difficile infections.
 
“Bacthera’s ambition is to enable our customers such as Seres Therapeutics to bring life-changing treatments to patients by pioneering the Live Biotherapeutic Product industry,” said Lukas Schüpbach, CEO, Bacthera. “With this significant agreement, we are one step closer to making that happen, and we are proud to be part of bringing an entirely new class of medicines to people who have a profound need for it. With our new Microbiome Center of Excellence in Visp, we are looking forward to supporting the manufacturing of potentially life-saving microbiome-based treatments, such as SER-109.”
 
Eric Shaff, CEO, Seres, said, “Our mission at Seres is to transform the lives of patients worldwide with revolutionary microbiome therapeutics. We are pleased with the progress we have made to prepare for an expected biologics license application submission in mid-2022, and look forward to partnering with Bacthera to expand upon our existing production capacity to meet demand growth beyond the initial phase of launch and help ensure eligible patients worldwide can receive this potential new treatment option.”
 
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 square meters with three manufacturing floors, including capacity for commercial production. One of the three manufacturing floors will be dedicated to the manufacturing of SER-109.
 
Jean-Christophe Hyvert, president, biologics and cell and gene, Lonza, said, “This collaboration truly exemplifies Bacthera’s leading offering for LBP manufacturing as a strategic partner on the path to commercialization. Bacthera will utilize a facility inspired by the Ibex Solutions to offer flexibility, speed, and assured supply, enabling its customers to mark a significant milestone in the advance of microbiome-targeting therapies.”
 
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.
 
Christian Barker, executive vice president health and nutrition, Chr. Hansen, said, “With Bacthera, we are on a mission to pioneer the future of medicine based on good bacteria. While Bacthera has already been successful in winning and executing several projects for customers based in Europe, the U.S., and Asia, we consider this first commercial manufacturing agreement a breakthrough in our microbiome lighthouse. This will support Bacthera in becoming a world-leading CDMO in the emerging Live Biotherapeutic Product industry.”