Seres Therapeutics inked an agreement with CDMO Bacthera to produce its lead microbiome-based treatment at Lonza’s expanding manufacturing facility in Visp, Switzerland.
Additionally, Bacthera is establishing a new Microbiome Center for Excellence dedicated to the manufacture of live biotherapeutic products (LBPs) on the Lonza campus.
Under terms of the agreement, the Microbiome Center will be about 12,000 square meters and have three manufacturing floors as well as capacity for commercial production, the companies said. Financial terms of the agreement weren’t disclosed.
One of the production floors will be dedicated to manufacturing SER-109—Seres’ phase 3 drug to treat Clostridium difficile infection—for commercial use. Seres expects to ask the FDA for approval by the middle of next year.
If approved, SER-109 could become the first product within the live biotherapeutic industry to be produced commercially.
“(We) 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 patients worldwide can receive this potential new treatment option,” Eric Shaff, CEO of Seres, said in a statement.
The company also has two other clinical-stage microbiome-based assets: phase 2 SER-287 and phase 1 SER-301, both for ulcerative colitis.
The microbiome market, which is expected to grow beyond $1 billion in the coming years, is attracting more attention and investment. The Centers for Disease Control and Prevention classifies CDI, which causes severe diarrhea and colitis, as one of the greatest microbial threats to human health.
Back in 2019, Lonza entered into a $105 million, 50-50 venture with Denmark’s Chr. Hansen as part of its plans to become the go-to contract provider for LBPs.
More recently, in October, Scottish biopharma EnteroBiotix announced it was building a 20,000-square-foot microbiome manufacturing facility. In September 2020, Arranta Bio, a fledgling CDMO, completed construction on a $100 million expansion effort focused on LBPs.
Also in September last year, Australian CDMO Luina Bio pledged to increase its clinical and commercial manufacturing of LBPs as part of its effort to broaden its biologics scope.