CMC Biologics, Inc., a global CMO dedicated to process development and production of biopharmaceuticals for clinical and commercial use, today announced that it will supply bulk drug substance for Emergent BioSolutions' recently FDA-approved product, IXINITY® [coagulation factor IX (recombinant)]. IXINITY is a lyophilized powder for solution for intravenous injection. It is a coagulation factor IX (recombinant) indicated in adults and children ≥ 12 years of age with hemophilia B for control and prevention of bleeding episodes, and for perioperative management. Hemophilia B is a bleeding disorder caused by a mutation on the factor IX gene resulting in a deficiency of clotting factor IX in the blood, which controls bleeding.
"Working in partnership with Emergent to achieve this important commercial milestone has been a major focus for the entire CMC Biologics team," said Gustavo Mahler, PhD, Global Chief Operations Officer of CMC Biologics. "We manufactured the coagulation factor IX (recombinant) drug substance for all of the clinical trials. We are proud to have played such an important role in the development of IXINITY."
CMC Biologics has an agreement with Emergent for the exclusive manufacture of the coagulation factor IX (recombinant) drug substance. CMC Biologics' facility in Bothell, WA was inspected by the FDA as part of the approval for the commercial manufacture of IXINITY.
"We are extremely pleased to help Emergent provide this critical treatment option to patients for management of hemophilia B," said Claes Glassell, Chief Executive Officer of CMC Biologics. "We are committed to providing innovative development and manufacturing solutions for all of our clients to bring their products to the market."