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Production of virus, which can be inactivated by the intravenous injection animal from immune serum globulin

机译:可以通过静脉注射动物从免疫血清球蛋白中灭活病毒的产生

摘要

Method of reducing the anticomplement activity (ACA) resulting from viral inactivation treatment of a solution of antibodies, the method comprising contacting the solution with a trialkylphosphate, such as tri-n-butyl phosphate, and a detergent, such as sodium cholate, under conditions sufficient to reduce substantially the virus activity, and then incubating the solution under controlled conditions of time, pH, temperature, and ionic strength such that the anticomplement activity is reduced to an acceptable level. In a preferred embodiment, the ACA is reduced to less than 60 CH50 units/mL, the incubation is for at least about ten days at a pH from 3.5 to 5.0, the temperature is maintained within a range of 2 to 50° C., and the ionic strength of the solution is less than about 0.001 M.
机译:降低由抗体溶液的病毒灭活处理引起的抗补体活性(ACA)的方法,该方法包括在一定条件下使溶液与磷酸三烷基酯(例如磷酸三正丁酯)和去污剂(例如胆酸钠)接触足以充分降低病毒活性,然后在控制的时间,pH,温度和离子强度条件下孵育溶液,以使抗补体活性降低至可接受的水平。在一个优选的实施方案中,将ACA降低至小于60 CH 50 / mL,在3.5至5.0的pH下温育至少约十天,温度保持在一定范围内。 2至50° C.,溶液的离子强度小于约0.001M。

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