A solvent I detergent treated, pasteurised and highly purified factor VIII concentrate

Area of Science:

• Biotechnology
• Virology
• Hematology

Background:

• Current virus inactivation methods for clotting concentrates are insufficient against heat- and solvent-resistant viruses.
• Human parvovirus B19 and hepatitis A virus (HAV) pose significant risks to hemophiliac patients.
• Existing pasteurization and solvent detergent (SID) treatments alone are inadequate.

Purpose of the Study:

• To develop an improved pasteurization process for factor VIII (FVIII) concentrates.
• To enhance virus inactivation efficacy, particularly against parvovirus B19 and HAV.
• To integrate a new pasteurization step into existing FVIII manufacturing and SID-treatment.

Main Methods:

• Developed a novel pasteurization procedure for FVIII at 63°C for 10 hours using a new stabilizer composition.
• Applied this pasteurization to purified FVIII already treated with solvent detergent (SID).
• Introduced a second purification step using an anion exchange resin.

Main Results:

• Achieved effective virus inactivation without discernible damage to the factor VIII/von Willebrand factor (FVIII/VWF) complex.
• The combined SID-treatment and enhanced pasteurization provide two independent virus inactivation steps.
• The additional anion exchange purification step further reduced virus levels compared to current FVIII preparations.

Conclusions:

• The enhanced pasteurization process is effective and compatible with FVIII manufacturing.
• This multi-step approach significantly improves virus safety for hemophiliac patients.
• The study presents a viable strategy to mitigate risks associated with virus transmission in clotting factor concentrates.