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.

• Keywords: Antihemophilic factor VIII; human immunodeficiency virus; solvent/detergent inactivation; chro-matog