Biotechnology and Bioprocess Engineering:BBE

The Korean Society for Biotechnology and Bioengineering (한국생물공학회)
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Enhanced Virus Safety of a Solvent/Detergent-Treated Anti-hemophilic Factor IX Concentrate by Dry-Heat Treatment

  • Shin Jeong-Sup (Green Cross Corp., Department of Molecular Science and Technology, College of Engineering, Ajou University) ;
  • Choi Yong-Woon (Green Cross Corp.) ;
  • Sung Hark-Mo (Green Cross Corp.) ;
  • Ryu Yeon-Woo (Department of Molecular Science and Technology, College of Engineering, Ajou University) ;
  • Kim In-Seop (Department of Biological Sciences, College of Natural Sciences, Hannam University)
  • Published : 2006.01.01
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Abstract

With particular regards to the hepatitis A virus (HAV), a terminal dry-heat treatment ($100^{\circ}C$ for 30 min) process, following lyophilization, was developed to improve the virus safety of a solvent/detergent-treated antihemophilic factor IX concentrate. The loss of factor IX activity during dry-heat treatment was of about 3%, as estimated by a clotting assay. No substantial changes were observed in the physical and biochemical characteristics of the dry-heat-treated factor IX compared with those of the factor IX before dry-heat treatment. The dry-heat-treated factor IX was stable for up to 24 months at $4^{\circ}C$, The dry-heat treatment after lyophilization was an effective process for inactivating viruses. The HAV and murine encephalomyocarditis virus (EMCV) were completely inactivated to below detectable levels within 10 min of the dry-heat treatment. Porcine parvovirus (PPV) and bovine herpes virus (BHV) were potentially sensitive to the treatment. The log reduction factors achieved during lyophilization and dry-heat treatment were ${\ge}5.60$ for HAV, ${\ge}6.08$ for EMCV, 2.64 for PPV, and 3.59 for BHV. These results indicate that dry-heat treatment improves the virus safety of factor IX concentrates, without destroying the activity. Moreover, the treatment represents an effective measure for the inactivation of non-lipid enveloped viruses, in particular HAV, which is resistant to solvent/detergent treatment.

Keywords

References

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