Biotechnology and Bioprocess Engineering:BBE

  • 제6권1호
  • /
  • Pages.25-30
  • /
  • 2001
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  • 1226-8372(pISSN)
  • /
  • 1976-3816(eISSN)
한국생물공학회 (The Korean Society for Biotechnology and Bioengineering)
권호 표지

Removal and Inactivation of Human Immunodeficiency Virus(HIV-1) by Cold Ethanol Fractionation and Pasteurization during the Manufacturing of Albumin and Immunoglobulins from Human Plasma

  • Kim, In-Seop (Technical Operations Service, Greencross Plasma Derivatives Corp.) ;
  • Eo, Ho-Gueon (Technical Operations Service, Greencross Plasma Derivatives Corp.) ;
  • Park, Chan-Woo (GreenCross Vaccine Corp.) ;
  • Chong E. Chang (Technical Operations Service, Greencross Plasma Derivatives Corp.) ;
  • Lee, Soungmin (Technical Operations Service, Greencross Plasma Derivatives Corp.)
  • 발행 : 2001.01.01
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초록

Viral safety is a prerequisite for manufacturing clinical albumin and immunoglobulins from human plasma pools. This study was designed to evaluate the efficacy of cold ethanol fractionation and pasteurization (60$\^{C}$ heat treatment for 10h) for the removal/inactivation of human immunodeficiency virus type 1 (HIV-1) during the manufacturing of albumin and immunoglobulins. Samples from the relevant stages of the production process were spiked with HIV-1, and the amount of virus in each fraction was quantified by the 50% tissue culture infectious dose(TCID(sub)50). Both fraction IV fractionation and pasteurization steps during albumin processing were robust and effective in inactivating HIV-1, titers of which were reduced from an initial 8.5 log(sub)10 TCID(sub)50 to undetectable levels. The log reduction factors achieved were $\geq$ 4.5 and $\geq$ 6.5, respectively. In addition, fraction III fractionation and pasteurization during immunoglobulins processing were robust and effective in eliminating HIV-1. HIV-1 titers were reduced from an initial 7.3 log(sub)10 TCID(sub)50 to undetectable levels. The log reduction factors achieved in this case were $\geq$ 4.9 and $\geq$ 5.3, respectively. These results indicate that the process investigated for the production of albumin and immunoglobulins have sufficient HIV-1 reducing capacity to achieve a high margin of safety.

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참고문헌

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