Chr Hansen and Lonza’s joint venture Bacthera and microbiome therapeutics company Seres Therapeutics are teaming up to manufacture SER-109, Seres’ lead product candidate for recurrent Clostridioides difficile infection (rCDI).
SER-109 consists of purified Firmicutes spores, based on their modulatory role in the life cycle of C. difficile and disease pathogenesis. Lonza highlights SER-109 has the potential to be the “first-ever” live biotherapeutic product (LBP) to be produced commercially.
“Bacthera can offer end-to-end development and manufacturing solutions for drug substances and drug products to the industry. We can now offer all development and manufacturing services required from early-stage development via clinical trials to commercial manufacturing,” Felix Faupel, chief commercial officer at Bacthera, tells NutritionInsight.
To expand upon Seres’ initial commercial manufacturing supply chain, Bacthera is establishing a dedicated facility to commercially manufacture SER-109 in its new Microbiome Center of Excellence (CoE) in Visp, Switzerland.
“With this collaboration and the Microbiome CoE, we show that the manufacture of live biotherapeutic products (LBPs) at commercial scale is not a roadblock for LBP-developing companies anymore,” adds Faupel.
A need for microbial treatments
According to Bacthera’s CEO Lukas Schüpbach, the collaboration brings “an entirely new class of medicines to people who have a profound need for it.”
Causing severe diarrhea and colitis, an inflammation of the colon, rCDI has been classified as one of the greatest microbial threats to human health by the Centers for Disease Control and Prevention.
Seres Therapeutics flags C. difficile is the leading cause of hospital-acquired infections in the US and is responsible for 170,000 hospitalizations and the deaths of more than 20,000 US adults annually.
The company also underscores there are currently “few options” to treat rDCI. Vancomycin pulse taper regimens are recommended by guidelines but have “modest efficacy” because they do not address the disrupted microbiome.
Other potential treatments for C. difficile include probiotic supplementation and transferring fecal microbes from a healthy donor to a patient.
Breaking ground on the new site
Bacthera “clearly sees” many production technologies used in development are not yet scalable or not applicable for commercial manufacturing.
“By establishing standard technologies in our Microbiome CoE, we support the industry to consolidate these technologies into something more standardized,” says Faupel.
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.
“Our dedicated manufacturing floor option also allows us to scale up productions, independently from the used manufacturing technology. The commercial manufacturing of SER-109 is the best example for such an up-scaling of a specific technology,” Faupel adds.
Being the potential first approved product for [rCDI] brings a “responsibility we take seriously to educate all stakeholders about the burden of this disease,” Kristin Ficks Ainsworth, senior vice president of corporate communications at Seres Therapeutics tells NutritionInsight.
Seres’ stakeholders include healthcare providers, payers, as well as patient advocacy organizations.
“We are utilizing all channels [for our educational efforts], including human resources as well as novel digital approaches, medical conferences and publications and will continue to ramp up these efforts as we prepare for a potential approval,” says Ainsworth.
Seres plans to submit the BLA in mid-2022. The US Food and Drug Administration has already granted SER-109 Breakthrough Therapy designation and Orphan Drug designation for the treatment of rCDI.
Overall, Bacthera and Seres’ integrated offering is expected to be “well recognized by the industry, LBP-developing companies and investors that have not yet invested in this field due to concerns of scalability and commercial manufacturing,” outlines Faupel.
In May, Bacthera became ready to start supplying LBPs following Swiss and Danish manufacturing licenses. At the time, the company explained how the LBP space is virgin territory because no LBP is on the market yet. Additionally, comparable services to what Bacthera offers to the LBP industry are “quite limited.”
“By removing this hurdle, we expect further innovation to rise,” asserts Faupel.
Bacthera was first announced in 2019. At the time, Bacthera said it would attract €90 million (US$104 million) in investment from Lonza and Chr. Hansen over the next three years.
This July, Seres Therapeutics entered an agreement with Nestlé Health Science to jointly commercialize SER-109 in the US and Canada.
Under the terms of the agreement, Nestlé Health Science will utilize its global pharmaceutical business Aimmune Therapeutics and will assume the role of lead commercialization party.
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