F8 Protein

Coagulation Factor VIII (FVIII), also known as anti-hemophilic factor (AHF), is a crucial blood clotting protein. It plays a vital role in the intrinsic pathway of blood coagulation, acting as a cofactor for factor IXa, which, in the presence of calcium ions and phospholipids, converts factor X to the activated form Xa. Deficiency or dysfunction of FVIII leads to hemophilia A, a genetic disorder characterized by excessive bleeding .

The journey of FVIII from plasma-derived products to recombinant technology has been remarkable. Initially, FVIII was isolated from human plasma, but this method posed significant risks, including the transmission of blood-borne pathogens such as HIV and hepatitis . The successful cloning of the FVIII gene in 1984 marked a significant breakthrough, enabling the production of recombinant human FVIII (rFVIII) . This advancement not only improved the safety profile of FVIII products but also ensured a consistent and reliable supply.

Recombinant FVIII is produced using genetic engineering techniques. The FVIII gene is inserted into the DNA of a host cell line, typically Chinese Hamster Ovary (CHO) cells, which are then cultured in bioreactors. These cells express the FVIII protein, which is subsequently purified through a series of chromatography steps to ensure high purity and activity .

Recombinant FVIII has revolutionized the treatment of hemophilia A. It provides a safer alternative to plasma-derived FVIII, significantly reducing the risk of viral transmission. Clinical trials have demonstrated the efficacy and safety of rFVIII in both prophylactic and on-demand treatment of bleeding episodes in patients with hemophilia A .