Journal of Microbiology

The Microbiological Society of Korea (한국미생물학회)
권호 표지

Solvent/Detergent Inactivation and Chromatographic Removal of Human Immunodeficiency Virus During the manufacturing of a High Purity Antihemophilic Factor VIII concentrate

  • Kim, In-Seop (Technical Operations Service , Greencross Plasma Derivatives Corp. and Greencross Corp. Korea) ;
  • Park, Yong-Woon (Technical Operations Service , Greencross Plasma Derivatives Corp. and Greencross Corp. Korea) ;
  • Woo, Hang-Sang (Technical Operations Service , Greencross Plasma Derivatives Corp. and Greencross Corp. Korea) ;
  • Chong E. Chang (Technical Operations Service , Greencross Plasma Derivatives Corp. and Greencross Corp. Korea) ;
  • Lee, Soungmin (Technical Operations Service , Greencross Plasma Derivatives Corp. and Greencross Corp. Korea)
  • Published : 2000.09.01
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Abstract

A validation study was conducted to determine the efficacy of solvent/Detergent (S/D) inactivation and Q-Sepharose column chromatographic removal of the human immunodeficiency virus (HIV) during the manufacturing of a high purity antihemopilic factor VIII (GreenMono) from human plasma. S/D treatment using the organic solvent, tri (n-butyl) phosphate, and the detergent, Trition X-100, was a robust and effective step in eliminating HIV-1. The HIV-1 titer was reduced from an initial titer of 8.3 log10 TCID50 to undetectable levels within one minute of S/D treatment, HIV-1 was effectively partitioned form factor VIII during Q-Sepharose column chromatography with the log reduction factor of 4.1 . These results strongly assure the safety of GreenMono From HIV.

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