Removal/neutralization of hepatitis A virus during manufacture of high purity, solvent/detergent factor VIII concentrate

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Abstract
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 Iog10 in the infectivity of hepatitis A virus.