CMC Biologics to Manufacture Behring’s Afstyla

CMC Biologics has entered an agreement to supply bulk drug intermediate for CSL Behring’s recently FDA-approved product, AFSTYLA [Antihemophilic Factor (Recombinant), Single Chain], its long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A.
 
CMC Biologics’ facility in Copenhagen, Denmark was inspected by the FDA as part of the approval for the commercial manufacture of AFSTYLA.
 
“Working together with CSL Behring to achieve this important commercial milestone has been a major focus for our entire team in Copenhagen,” said Patricio Massera, Ph.D., site head and general manager of CMC Biologics’ Copenhagen facility. “We are proud to have played an important role on the clinical development and manufacturing of the recombinant factor VIII single-chain of AFSTYLA.”