Date: 2015-05-05
Type of information: Production agreement
Compound: Ixinity® (coagulation factor IX)
Company: CMC Biologics (Denmark - USA) Emergent BioSolutions (USA - MD)
Therapeutic area: Rare diseases - Genetic diseases - Hematological diseases
Type agreement: manufacturing production
Action mechanism: protein/coagulation factor. Ixinity® 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.
Disease: hemophilia B
Details: * On May 05, 2015, 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)]. 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®.
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