Simoctocog Alfa, Recombinant B-domain deleted (BDD) rFVIII

Specification

• Cat#: THP-0092
• Product Name: Simoctocog Alfa, Recombinant B-domain deleted (BDD) rFVIII
• Description: The product is a recombinant B-domain deleted (BDD) rFVIII produced in HEK293F cells. The harvested product is concentrated and purified by a series of chromatography steps. The product 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.
• Sequences: Not Available
• Species: Human
• Molecular Weight: 170000.0 Da (Approximate, B-Domain deleted)
• Source: HEK293 Cells
• Purity: >99% by SDS-Page and HPLC analysis
• Cas No: 1219013-68-9
• Formula: Not Available
• Endotoxin Level: <0.001 EU per 1 μg by the LAL method
• Biological Activity: 2000IU/2.5mL

Pharmaceutical Information

• Pharmaceutical Application: Simoctocog Alfa
• Applications: Indicated for the treatment and prophylaxis of bleeding in patients of all ages with haemophilia A (congenital factor VIII deficiency).
• Examples of Clinical Use: Haemophilia A (congenital factor VIII deficiency)
• Pharmacodynamics: The product is an antihemorrhagic agent that displays comparable hemostatic efficacy as the endogenous coagulation factor VIII. Following administration of the product, an increase plasma levels of factor VIII is observed to temporarily correct factor VIII deficiency and bleeding tendencies.
• Mechanism of action: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C. The disorder is associated with episodes of recurrent bleeding and profuse bleeding into joints, muscles or internal organs, either spontaneously or as results of accidental or surgical trauma.
• Affected organisms: Not Available
• Targets: Target 1. von Willebrand factor