Bacthera, a specialised contract development and manufacturing organization (CDMO), has announced that it has acquired a cGMP manufacturing site in León (Spain) 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.
Baker advised Bacthera with a team formed by partners Cecilia Pastor and Juanjo Corral, with the support of counsel Alba Anegón and senior associate Eugenia Vázquez. Baker McKenzie London advised with senior associate Alexander Gee and associate Andrew Tyau.
