World Hemophilia Day 2024-Tofflon Integrated Solution of High-purity vWF Concentrate

The usual cause of von Willebrand disease (vWD) is an inherited abnormal gene that controls von Willebrand factor (vWF) — a protein that plays a key role in blood clotting. If vWD is diagnosed based on reduced plasma vWF levels, the incidence is expected to be 1%. While, judging from obvious bleeding symptoms accompanied by reduced vWF levels, the incidence of vWD is 1/1000.

vWD has been treated by substitutive therapy using whole plasma, cryoprecipitate, or FVIII concentrates containing a sufficient quantity of vWF. Efficient replacement therapy for the management of a specific coagulation disorder should target to infuse only the defective protein while avoiding unnecessary proteins, which can cause protein overload and other potential side effects. Whole plasma and cryoprecipitate are considered to contain the undamaged protein since they are often effective in reducing bleeding time, although inconsistent results have also been reported. FVIII concentrates have the advantage of offering a concentrated form of the protein and may be virus inactivated.

Tofflon, as a leader of the smart solution deliver of biopharmaceutical industry, has developed the integrated solution of high-purity vWF concentrate with a low FVIII content plasma derived medical products. Highly purified von Willebrand factor (vWF) concentrate has been prepared from cryoprecipitate by a three-step chromatographic procedure (integrated with FVIII and fibrinogen purification processes) using 2 anion exchangers and immobilized gelatin polishing (to remove fibronectin). Viral reduction is by S/D and terminal dry heat at 80℃ for 72 hours. The produced vWF based on Tofflon’s solution has been commercially available, has been proven to be highly safe and efficient means of treating vWD.

Tofflon has made great progress in PDMPs process design, production system equipment and consumable supply, and technology transfer in cooperation with PDMPs manufacturers. We are welcoming industry peers and new partners to work together and contribute to the development of plasma products and raising the capability of rare diseases treatment. Warmly welcome to contact us [email protected].