CMC Biologics, a global leader in clinical and commercial manufacturing of monoclonal antibodies, coagulation factors and other therapeutic proteins, 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 haemophilia A, to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and the perioperative management of bleeding.
“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, PhD, site head & 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.”
CMC Biologics has an agreement with CSL Behring for the manufacture of the first intermediate of recombinant factor VIII single-chain drug substance. CMC Biologics’ facility in Copenhagen, Denmark was inspected by the FDA as part of the approval for the commercial manufacture of Afstyla.
“We are extremely pleased to help CSL Behring provide this critical treatment option to patients for management of haemophilia A,” said Gustavo Mahler, PhD, president & chief executive officer of CMC Biologics. “With marketed products manufactured in both our Seattle and Copenhagen facilities, we provide robust commercial solutions and experience for our clients on both continents. Our commitment to deliver on our client’s products is prioritized across the entire organization.”