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Removal/neutralization of hepatitis A virus during manufacture of high purity, solvent/detergent factor VIII concentrate
Author(s) -
Lemon Stanley M.,
Murphy Paula C.,
Smith Andrew,
Zou Jinsheng,
Hammon John,
Robinson Stephen,
Horowitz Bernard
Publication year - 1994
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/jmv.1890430109
Subject(s) - neutralization , infectivity , chemistry , virus , virology , solvent , hepatitis a virus , ion chromatography , chromatography , hepatitis c virus , hepatitis b virus , antibody , hepatitis , hepatitis virus , biochemistry , biology , immunology
Recent reports have suggested an increased risk of type A viral hepatitis in hemophilic patients treated with high purity factor VIII concentrates prepared using ion exchange chromatography coupled with solvent/detergent treatment for in‐activation of viruses. To determine the capacity for removal or inactivation of hepatitis A virus during the factor VIM manufacturing process, human plasma and various factor VIM production intermediates were spiked with cell culture‐propagated virus and subjected to scaled down conditions mimicking the manufacture of solvent/ detergent factor VIII. The combination of antibody‐mediated neutralization, cryoprecipitation, anion exchange chromatography, and lyophilization in the absence of sucrose resulted in a minimal reduction of 5.5 to 8.55 Iog 10 in the infectivity of hepatitis A virus. © 1994 Wiley‐Liss, Inc.