Solvent/Detergent Inactivation and Chromatographic Removal of Human Immunodeficiency Virus During the Manufacturing of a High Purity Antihemophilic Factor 8 Concentrate

Kim In-Seop; Choi Yong-Woon Greencross Plasma Derivatives Corp. and Greencross Corp, Yongin

Solvent/Detergent Inactivation and Chromatographic Removal of Human Immunodeficiency Virus During the Manufacturing of a High Purity Antihemophilic Factor 8 Concentrate

2000

Kim In-Seop | Choi Yong-Woon Greencross Plasma Derivatives Corp. and Greencross Corp, Yongin (Korea Republic)

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 antihemophilic factor 8 (GreenMono) from human plasma. S/D treatment using the organic solvent, tri (n-butyl) phosphate, and the detergent, Triton 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 from factor 8 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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