Lemon S M, Murphy P C, Smith A, Zou J, Hammon J, Robinson S, Horowitz B
Department of Medicine, University of North Carolina, Chapel Hill 27599-7030.
J Med Virol. 1994 May;43(1):44-9. doi: 10.1002/jmv.1890430109.
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 inactivation of viruses. To determine the capacity for removal or inactivation of hepatitis A virus during the factor VIII manufacturing process, human plasma and various factor VIII 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 log10 in the infectivity of hepatitis A virus.
最近的报告表明，在接受使用离子交换色谱结合溶剂/去污剂处理以灭活病毒的高纯度因子VIII浓缩物治疗的血友病患者中，甲型病毒性肝炎的风险增加。为了确定在因子VIII制造过程中甲型肝炎病毒的去除或灭活能力，用人血浆和各种因子VIII生产中间体接种细胞培养繁殖的病毒，并在模拟溶剂/去污剂因子VIII制造的缩小条件下进行处理。在没有蔗糖的情况下，抗体介导的中和、冷沉淀、阴离子交换色谱和冻干相结合，导致甲型肝炎病毒的感染性最低降低5.5至8.55个对数10。
