The Biberach site in Germany is the location of Europe's largest biopharmaceutical plant for the development and manufacture of therapeutic proteins and antibodies from mammalian cell cultures. Boehringer Ingelheim BioXcellence™ operates one pilot plant and two large-scale manufacturing plants in Biberach for its contract manufacturing business.
The manufacturing facility in Biberach offers tailor-made contract development and manufacturing services to the biopharmaceutical industry, providing the entire production technology chain from DNA to Fill & Finish. The experienced staff at Boehringer Ingelheim BioXcellence™ has developed economically viable processes which ensure customer supply with short und flexible timelines.
Commercial manufacturing is taking care to ensure robust project transfers and to reliably secure customer supply. Working in global and multidisciplinary teams, experienced staff facilitates the technical transfer from the customer directly to the commercial plant. Fed-batch processes are a core technology, but Biberach also offers perfusion processes in 2,000 L fermenters established within the commercial plant. Over the last few years, numerous products have been successfully transferred into commercial manufacturing plants.
Clinical Supply Facility
We have more than 15 years of experience in manufacturing clinical and commercial cell banks (CHO, NS0, SP2/0) under GMP. About 200 master, working and bioassay cell banks have been generated and released during this time.
Upstream / Downstream
Our experience in upstream and downstream encompasses more than 60 different products and about 80 different processes for manufacturing pre-clinical and clinical material. The clinical material capacities offer a flexible scale of up to 2,000 L.
The single-use plant houses bioreactors from 100 L to 500 L as well as a fully disposable downstream processing facility.
Fill & Finish
With more than 25 years of experience in clinical Fill & Finish, we can operate liquid and lyophilized products under GMP conditions for Tox, Clinical Phase I and II as well as reference standards, diluents and stability batches in vials, prefilled syringes, single- and dual-chamber cartridges.
Our biomanufacturing capacities for clinical and commercial material are characterized by a flexible scale of up to 15,000 L.