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CMC Biologics Cleared for Commercial Manufacture of CSL Behring's FDA-Approved AFSTYLA®

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Bulk Drug Intermediate Produced in CMC Biologics’ Copenhagen, Denmark Facility

COPENHAGEN, Denmark and BOTHELL, Wash. – June 16, 2016 CMC Biologics, a global leader in clinical and commercial manufacturing of monoclonal antibodies, coagulation factors and other therapeutic proteins, today announced that it will supply bulk drug intermediate for CSL Behring’s recently FDA-approved product, AFSTYLA® [Antihemophilic Factor (Recombinant), Single Chain], its novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A, to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and the perioperative management of bleeding.

CMC Biologics Expands GMP Manufacturing Capacity in Europe

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Addition of a Bioreactor 3PACK™ Production Facility to its Copenhagen Facility Provides Additional Flexible Soultions for Clients

BOTHELL, Wash., Berkeley, Calif., USA, and COPENHAGEN, Denmark – June 2, 2016 (GLOBE NEWSWIRE) – CMC Biologics, a global leader in clinical and commercial manufacturing of monoclonal antibodies, coagulation factors and other therapeutic proteins, announced today that, as part of its ongoing global manufacturing capacity expansion, it has completed the first stage of the expansion for its manufacturing facility in Copenhagen, Denmark with the addition of a single-use Bioreactor 3PACK™ facility. The Bioreactor 3PACK™ configuration consists of three 2,000L single-use production bioreactors and associated seed train for scale up, allowing for flexible production with scales from 2,000L to 6,000L in a single production suite. The bioreactors can be run singly, simultaneously, sequentially or in staggered fashion to achieve desired production needs. The 3PACK™ line is ready for production runs in June 2016.