CMC Biologics is a results-oriented contract biopharmaceutical manufacturing and development organization (CMO). We focus solely on contract work and are experienced in all phases of development, manufacturing, and quality. We have the ability to provide complete, full-service manufacturing – from DNA to active pharmaceutical ingredient (API) – as well as extensive process, analytical, and formulation development capabilities.
With facilities strategically located in Copenhagen, Denmark and Seattle, Washington (USA), we are equipped to work with clients all over the world. In addition to the broad client base we serve, we also have experience working with global regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Capabilities Overview
- Contract Manufacturing Organization (CMO) with microbial and mammalian capabilities
- Global reach, with two strategically located sites
- Complete, full-service manufacturing, from DNA to active pharmaceutical ingredient (API)
- Comprehensive turnkey or stand-alone services
- Stainless steel and single-use bioreactors
- Proprietary cell line development platform, CHEF1®, which provides high-titer, rapid expression
- Clinical and commercial experience in recombinant proteins and monoclonal antibodies
- Extensive expertise in process, analytical, and formulation development