Biotechnology and Bioprocess Engineering:BBE

The Korean Society for Biotechnology and Bioengineering (한국생물공학회)
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Cold Ethanol Fractionation and Heat Inactivation of Hepatitis A Virus During Manufacture of Albumin from Human Plasma

  • Kim, In-Seop (Department of Biological Sciences, Hannam University) ;
  • Park, Yong-Woon (Central Research Center, Green Cross Plasma Derivatives Company) ;
  • Lee, Sung-Rae (Central Research Center, Green Cross Plasma Derivatives Company) ;
  • Sung, Hark-Mo (Central Research Center, Green Cross Plasma Derivatives Company)
  • Published : 2004.01.01
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Abstract

The purpose of the present study was to examine the efficacy and mechanism of fraction IV cold ethanol fractionation and pasteurization (60$^{\circ}C$ heat treatment for 10 h), involved in the manufacture of albumin from human plasma, in the removal and/or inactivation of the hepatitis A virus (HAV). Samples from the relevant stages of the production process were spiked with HAV and the amount of virus in each fraction then quantified using a 50% tissue culture infectious dose (TCID$\_$50/). HAV was effectively partitioned from albumin during the fraction IV cold ethanol fractionation with a log reduction factor of 3.43. Pasteurization was also found to be a robust and effective step in inactivating HAV, where the titers were reduced from an initial titer of 7.60 log TCID$\_$50/ to undetectable levels within 5 h of treatment. The log reduction factor achieved during pasteurization was $\geq$4.76. Therefore, the current results indicate that the production process for albumin has sufficient HAV reducing capacity to achieve a high margin of virus safety.

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