[Factor VIII concentrate, highly purified and heated in solution (author's transl)]

Area of Science:

• Biochemistry
• Hematology
• Virology

Context:

• Hemophilia A treatment relies on factor VIII concentrate.
• Current purification methods require optimization for safety and efficacy.
• Viral inactivation is a critical step in blood product manufacturing.

Purpose:

• To describe a novel purification process for factor VIII concentrate.
• To evaluate the efficacy of heat treatment in reducing viral load.
• To characterize the purity and properties of the final factor VIII concentrate.

Summary:

• A purification process involving aluminum hydroxide adsorption, heat denaturation of fibrinogen, and sodium chloride precipitation was developed.
• Factor VIII concentrate was heated in a saccharose/glycine solution at 60°C for 10 hours.
• The final product exhibited high purity (6 units F VIII:C/mg protein), a F VIII R:Ag/F VIII:C ratio of 3, and was free from coagulable proteins and gamma-globulins.

Impact:

• The heating step demonstrated significant reduction of hepatitis B virus infectivity in chimpanzee models.
• This purification method yields a highly purified and potentially safer factor VIII concentrate.
• The process offers an effective strategy for viral inactivation in factor VIII concentrates.