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Related Experiment Videos

Virus validation experiments on the production process of OCTAVI SDPlus

L Biesert1, S Lemon, H Suhartono

  • 1Chemotherapeutisches Forschungsinstitut Georg-Speyer-Haus, Frankfurt am Main, Germany.

Blood Coagulation & Fibrinolysis : an International Journal in Haemostasis and Thrombosis
|July 1, 1995
PubMed
Summary

Modified pasteurization effectively inactivates viruses in Factor VIII concentrates. This enhanced viral safety, combined with existing methods, offers superior protection against viral contamination in blood products.

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Area of Science:

  • Biotechnology
  • Virology
  • Hematology

Background:

  • Factor VIII concentrates are essential for treating hemophilia.
  • Ensuring viral safety in blood products is critical.
  • Previous viral inactivation methods have limitations.

Purpose of the Study:

  • To evaluate the efficacy of modified pasteurization for viral inactivation in Factor VIII concentrate.
  • To assess the combined effect of pasteurization and solvent/detergent treatment on viral safety.
  • To introduce a novel, highly purified Factor VIII concentrate (OCTAVI) with enhanced viral inactivation.

Main Methods:

  • Modified pasteurization: heating at 63°C for 10 hours in solution.
  • Testing viral inactivation against a panel of enveloped and non-enveloped viruses.

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  • Utilizing European Union guidelines for efficacy assessment.
  • Evaluating the combined effect with solvent/detergent treatment.

    • Main Results:

    • Modified pasteurization achieved >4.5 log10 TCID50 inactivation for tested viruses.
    • Both enveloped (HIV, HSV, pseudorabies) and non-enveloped (poliovirus, coxsackievirus, hepatitis A) viruses were inactivated.
    • The combined method (OCTAVI SDPlus) demonstrated superior viral safety compared to single-inactivation methods.

    Conclusions:

    • Modified pasteurization is a highly effective method for inactivating a broad spectrum of viruses in Factor VIII concentrates.
    • The double virus-inactivated Factor VIII concentrate (OCTAVI SDPlus) offers significantly improved viral safety.
    • This approach enhances the safety profile of blood products for transfusion.