Innovative coagulation factors: albumin fusion technology and recombinant single-chain factor VIII

Albumin fusion technology has been used to enhance the pharmacokinetic properties of recombinant coagulation factors. The goal of linking albumin to coagulation factors is to extend the half-life of the coagulation factor, thereby allowing for less frequent dosing for patients with bleeding disorders, such as hemophilia. The novel recombinant fusion proteins linking coagulation factors VIIa and IX with albumin (rVIIa-FP and rIX-FP, respectively) have a longer half-life and similar hemostatic efficacy compared with available recombinant coagulation factor products. Clinical evaluation of these fusion proteins is underway, and preliminary results with rIX-FP in patients with hemophilia B are encouraging. Other advances in coagulation factor therapy include a unique recombinant single-chain factor VIII (FVIII) protein, which has improved intrinsic stability and a higher affinity for von Willebrand factor (VWF), relative to other recombinant FVIIIs, and a recombinant VWF-albumin fusion protein (rVWF-FP), which has a significant longer half-life compared to available VWF products. Evaluation of these novel recombinant proteins continues and will help determine their potential to enhance the management of patients with bleeding disorders.