Basel, Switzerland, and Hørsholm, Denmark, March 13th 2023 – Bacthera, a specialized contract development and manufacturing organization (CDMO), announced today that it has acquired a cGMP manufacturing site in León (ES) from 4D Pharma. Acquiring 4D Pharma León, S.L.U., 4D Pharma’s Spanish subsidiary, will provide Bacthera with relevant production assets and approximately 40 employees.
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. Bacthera will build upon the León team’s strong track record of GMP LBP batch production for clinical supply in the US and EU to offer end-to-end solutions to its global customers.
The acquisition marks a significant milestone in Bacthera’s growth, and will enable the specialist CDMO to greatly increase production volumes, providing additional LBP manufacturing capacity for customers. The capabilities of the León site will increase efficiency and agility, reduce delivery timelines and support in meeting demand for large volumes for clinical supply.
The site’s infrastructure allows for GMP production of strict anaerobic and difficult-to-handle strains at different scales. In addition, the site’s tray freeze drying technologies offer an established and viability- retaining drying method which complements Bacthera’s existing spray drying technologies.
With its existing development and clinical manufacturing capabilities for both drug substance and drug product, alongside the commercial manufacturing facility in Visp (CH) and the acquisition in León, Bacthera will be able to offer an unprecedented end-to-end solution to the entire LBP market. Bacthera anticipates that it will begin clinical manufacturing operations from the end of Q1 2023.
As part of its investment, Bacthera is planning to upgrade the site infrastructure and downstream processes, including the introduction of state-of-the-art filtration and spray drying technologies.
Lukas Schüpbach, CEO, Bacthera, commented:
“This acquisition allows us to bridge our capabilities in development with our solutions for commercial manufacturing, adding capacity for the entire LBP market. Additionally, offering the direct transfer of clinical manufacturing into the León site will allow our customers to accelerate their products on the path to commercialization.”
To learn more about Bacthera’s LBP-related services, visit: https://www.bacthera.com/what-we- do/products-services/
About Live Biotherapeutic Products:
Live Biotherapeutic Products, LBPs for short or more popularly known as bugs-as-drug, are a new therapeutic modality being developed by a range of biotech and pharma companies across the world. LBPs are unique because their active substance is a living organism, most commonly a bacterium, that has been identified as showing promise in treating one or sometimes several diseases. LBPs are diverse and can consist of e.g. a single organism, a genetically modified organism, or a consortium of organisms.
Bacthera was founded in 2019 as a 50:50 Joint Venture of Chr. Hansen A/S and a Lonza Group Affiliate to specifically serve the needs of the emerging LBP industry. Bacthera’s expertise and the capabilities of production of bacteria for pharmaceutical purposes were transferred by both parent companies to Bacthera right from the beginning. Bacthera offers a compelling set of services across the LBP life cycle and process chain, from technical R&D development right through to GMP manufacture and QC testing of drug substance and drug product.
Bacthera operates from its Headquarters and Center of Excellence for drug product process development and manufacturing, and QC analytical testing in Basel, CH, and its Center of Excellence for drug substance process development, analytical development, and manufacturing in Hørsholm, DK.
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