| Definition | Simoctocog alfa is a recombinant B-domain deleted (BDD) rFVIII produced in genetically modified human embryonic kidney (HEK) 293F cells. The harvested product is concentrated and purified by a series of chromatography steps. It is an antihemorrhagic agent used as a replacement therapy in individuals with Haemophilia A who lack the factor VIII in the intrinsic pathway of blood coagulation system. As patients with haemophilia A are predisposed to episodes of recurrent bleeding [L1115], simoctocog alfa can be administered for the treatment or prevention of bleeding such as prior to surgical procedures.
Simoctocog alfa is a glycoprotein consisting of 1440 amino acids with an approximate molecular mass of 170 kDa, comprising the FVIII domains A1-A2 + A3-C1-C2 whereas the B-domain, present in the full-length plasma-derived FVIII, has been deleted and replaced by a 16 amino acid linker. Simoctocog alfa is a fourth-generation BDD FVIII product made in the human embryonic kidney (HEK) cell line. Full human post-translational modifications via elimination of potentially immunogenic glycosylation patterns found in non-human cell lines led to decreased immunogenicity and longer half-life [A31525]. |
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