| Title | Solvent/Detergent Inactivation and Chromatographic Removal of Human Immunodeficiency Virus During the Manufacturing of a High Purity Antihemophilic Factor Ⅷ Concentrate |
|---|---|
| Author | In Seop Kim *, Yong Woon Choi, Hang Sang Woo, Chong E. Chang 1 , and Soungmin Lee 1 |
| Address | 1 Technical Operations Service, Greencross Plasma Derivatives Corp. and Greencross Corp., 227-3 Kugal-Ri, Kiheung-Eup, Yongin City, Kyunggi-Do, 449-90 |
| Bibliography | Journal of Microbiology, 38(3),187-191, 2000, |
| DOI | |
| Key Words | Antihemophilic factor VIII, human immunodeficiency virus, solvent/detergent inactivation, chro-matog |
| 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 antihemophilic factor VIII (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 log 10 TCID 50 to undetectable levels within one minute of S/D treatment. HIV-1 was effectively partitioned from 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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