Pasteurization as an efficient method to inactivate blood borne viruses in factor VIII concentrates

Area of Science:

• Biotechnology
• Hematology
• Virology

Background:

• Haemophiliacs are at high risk of viral infections from blood products.
• Factor VIII concentrate is crucial for treating haemophilia A.
• Ensuring viral safety in factor VIII concentrates is paramount.

Purpose of the Study:

• To evaluate the safety and efficacy of pasteurized factor VIII concentrate (Haemate P).
• To assess the risk reduction of viral transmission in haemophiliacs.
• To determine the impact of pasteurization on factor VIII antigenicity and physiological properties.

Main Methods:

• Review of experimental and clinical studies on pasteurized factor VIII.
• Assessment of viral inactivation efficacy against hepatitis B, non-A, non-B hepatitis, AIDS, and herpes viruses.
• Evaluation of changes in factor VIII antigenicity and physiological properties post-pasteurization.

Main Results:

• Pasteurization at 60°C for 10 hours effectively reduces viral transmission risks.
• No new antigenic determinants were formed on factor VIII post-pasteurization.
• Physiological properties of factor VIII remained largely unaltered in patients.
• A slight loss in coagulant activity was observed but deemed acceptable.

Conclusions:

• Pasteurized factor VIII concentrate (Haemate P) is safe for haemophiliacs regarding major viral infections.
• The pasteurization process does not compromise the therapeutic quality or amount of factor VIII.
• The benefits of viral safety outweigh the minor loss in coagulant activity.