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Porcine factor VIII: current status and future developments.

C R M Hay1

  • 1University Department of Haematology, Manchester Royal Infirmary, Oxford Road, Manchester M13 9WL, UK. haemophilia@man.ac.uk

Haemophilia : the Official Journal of the World Federation of Hemophilia
|March 8, 2002
PubMed
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High-purity porcine factor VIII (pFVIII) is effective for patients with FVIII inhibitors but has side effects. A new generation pFVIII aims for improved safety and efficacy with advanced purification and viral attenuation.

Area of Science:

  • Hematology
  • Biotechnology
  • Pharmaceutical Science

Background:

  • Porcine factor VIII (pFVIII) is effective for treating bleeds in patients with factor VIII (FVIII) inhibitors, showing high efficacy in up to 90% of cases.
  • Current pFVIII products have limitations including potential transient falls in platelet count, transfusion reactions, and lack of viral attenuation, despite extensive screening.
  • A median of 15% cross-reactivity to pFVIII is observed in patients with FVIII inhibitors, with lower rates in acquired hemophilia.

Purpose of the Study:

  • To describe the development of a third-generation porcine factor VIII (pFVIII) concentrate.
  • To detail the enhanced purification and viral attenuation strategies for the new pFVIII product.
  • To anticipate the improved clinical profile, including efficacy, safety, and viral safety, of the next-generation pFVIII.

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Main Methods:

  • Development of a third-generation pFVIII using immuno-purification, ion-exchange chromatography, and washing.
  • Screening of source plasma for porcine parvovirus and application of a 4-cell line general screen for porcine viruses.
  • Viral attenuation using the solvent-detergent method, with spiking experiments suggesting a 6-log viral reduction.

Main Results:

  • The new pFVIII is expected to be ultra-pure, lacking porcine von Willebrand factor, with a specific activity of approximately 5000 U mg(-1) protein.
  • The product will not require albumin as a stabilizer and can be stored at 2-4 degrees Celsius.
  • Anticipated outcomes include enhanced viral safety, improved side-effect profile, no impact on platelet count, and reduced risk of transfusion reactions.

Conclusions:

  • The third-generation pFVIII represents a significant advancement over current products.
  • This novel concentrate is poised to offer superior clinical effectiveness and safety for patients with FVIII inhibitors.
  • Clinical trials are planned to validate the anticipated benefits of this next-generation pFVIII product.