The contract development and manufacturing organization (CDMO) has now assumed operational responsibility for the plant; the 200 CSL employees have also joined Thermo Fisher.
Site construction is not expected to be completed until 2022.
Originally, CSL Behring had decided to build the Lengnau production facility to manufacture its own recombinant coagulating factors, among other products. Work on the site began in 2014.
But in May 2020, Thermo Fisher signed off on a long-term lease agreement with CSL that would see the CDMO take over operations at the site.
As to why CSL had decided to lease the facility, Paul McKenzie, chief operating officer at CSL, said at the time: “As part of the CSL board of directors' strategic review, we are in the process of transforming our end-to-end supply chain with a view to ensuring the company's global manufacturing network is operating at a best-in-class level.”
This would see the biotech balance internal investment with access to ‘capabilities and capacities’ that are available through working with a CDMO, he added.
Long-term goal
For Thermo Fisher, the facility adds an additional location to its European network, as well as continues its strategic push to invest more funds into the biologics side of its business.
In terms of the kind of biologics projects this plant can address, the organization outlined how it would initially support manufacturing of CSL's next-generation recombinant factor IX product, Idelvion, for patients with hemophilia B. Over time, the goal is to widen the use of site to include additional biopharma customers.
The Lengnau facility has highly flexible bioproduction technologies, including both single-use and stainless steel with up to 12,500L bioreactor capacity, which provides biopharma companies a pathway from development to large-scale production as manufacturing needs evolve.
Thermo Fisher's biologics manufacturing network includes Princeton, New Jersey and St. Louis, Missouri, US; Groningen, in the Netherlands; Brisbane, Australia; and Hangzhou, China.
