CMC's headquarters include pilot and production facilities.
The state-of-the-art facility includes dedicated mammalian cell culture and microbial fermentation based production lines for the manufacture of biopharmaceutical drug substances for the use in phase I, II, and III clinical trials as well as commercial sale.
The facility is situated in the Danish part of 'Medicon Valley' in the greater Copenhagen area (Gladsaxe). It includes microbial fermenters up to 2000 L and mammalian bioreactors up to 1000 L.
The facility has been designed for technical flexibility, optimal segregation of products, and effective cleaning of equipment. It complies with strict cGMP requirements and facilitates frequent customer audits. Numerous audits have evaluated the Copenhagen facility to set new standards for the CMO industries.
The facility was approved by EMEA in July 2004, August 2005 and in January 2008 for manufacture of human Biologics.