Efmoroctocog alfa, Recombinant factor VIII, Fc tagged
The product is a fully recombinant factor VIII-Fc fusion protein (rFVIIIFc) with an extended half-life compared with conventional factor VIII (FVIII) preparations, including recombinant FVIII (rFVIII) products such as Moroctocog alfa. Factor VIII is a blood coagulant factor involved in the intrinsic pathway to form fibrin, or a blood clot. The product is a first commercially available rFVIII-Fc fusion protein (rFVIIIFc) where the conjugated molecule of rFVIII to polyethylene glycol is covalently fused to the dimeric Fc domain of human immunoglobulin G1, a long-lived plasma protein. The B domain of factor VIII is deleted.
220000.0 Da (Apparent, B-domain deleted)
>99% by SDS-Page and HPLC analysis
<0.001 EU per 1 μg of the protein by the LAL method
Indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Examples of Clinical Use:
Haemophilia A (congenital factor VIII deficiency)
In two multinational, open-label, noncomparative phase III trials involving previously treated pediatric and adult patients with severe haemophilia A, the clinical efficacy and safety of the product have been studied. The bleeding episodes were adequately controlled and bleeding rates were substantially reduced when the product has been used for individualized prophylaxis or treatment of bleeding. In adult patients receiving a single preoperative dose to maintain haemostasis during surgical procedures, the total dose on the day of surgery needed to maintain haemostasis ranged from 50.8 to 126.6 IU/kg.
Mechanism of action:
Factor VIII exists in a circulating protein complex consisting of two molecules via a non-covalent binding interaction; Factor VIII and von Willebrand factor. This complex remains inactive until the coagulation cascade is initiated, which activated factor VIII. Factor VIII is released from the protein complex upon activation and acts as a cofactor for factor IX-mediated conversion of factor X to activated factor X on phospholipid surfaces. Activated factor X is critical in converting prothrombin into thrombin and sequentially, thrombin converts fibrinogen to fibrin for the formation of a blood clot.
For research use only. Not intended for any clinical use. No products from Creative BioMart may be resold, modified for resale or used to manufacture commercial products
without prior written approval from Creative BioMart.
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