Locations

Bacthera’s drug substance Center of Excellence in Denmark stands for extensive know-how in microbial DS process development and analytical development. With a current headcount of 40 employees and growing, the site can support customers with a broad range of development and manufacturing capabilities:

• Cell banking
• Drug substance process development
• Analytical development
• GMP manufacturing for clinical trials

Bacthera’s newest site in Léon was acquired in early 2023 from 4D Pharma. The León facility embodies excellence in microbial drug substance cGMP manufacturing, reinforcing our capabilities in drug development and clinical supply capacity. The León site is a GMP-certified, proven live biotherapeutic product (LBP) manufacturing plant equipped with bioreactors of various sizes up to 3,500 L. The León team has a strong track record of 30 GMP LBP batches produced annually for clinical supply and will further enable end-to-end solutions to Bacthera’s global customers. With a headcount of 40 employees, the site provides:

• Drug substance process development
• Pre-clinical to phase III GMP manufacturing up to 3’500L
• QC
• Up- and downstream innovation under GMP

Bacthera’s Drug Product Center of Excellence in Switzerland stands for extensive know-how in microbial DP process development, DP GMP manufacturing, and QC. The site is furthermore the headquarters of Bacthera and with a current headcount of 40 employees and growing, the site can support customers with high-quality DP solutions for development and manufacturing:

• Drug product development
• QC
• GMP manufacturing for clinical trials

Bacthera’s Microbiome Center of Excellence, MC4a, is strategically nestled within Lonza’s Visp industry park and is a testament to our commitment to pioneering excellence in microbiome-based therapies. MC4a exemplifies innovation and efficiency, harnessing Lonza’s renowned Ibex® Solutions concept for manufacturing to empower early commercial launches and production. With a footprint spanning approximately 12,000 square meters and three dedicated manufacturing floors, including capacity for commercial production, MC4a will drive the advancement of microbiome-based therapeutics, standing on the back of 60 employees with extensive DS and DP experience. Notably, one of these manufacturing floors will be exclusively dedicated to the production of Vowst™, a groundbreaking therapy from Seres Therapeutics. The site offers:

• Dedicated customer manufacturing suites
• Multi-product LBP production line, suited for spore-formers and consortia products
• Fermentation capacities up to 2*10’000L
• Up to 200’000 capsules per hour