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1. 发明授权

US06686191B1 Preparation of virally inactivated intravenously injectable immune serum globulin 失效
标题翻译：病毒灭活静脉注射免疫血清球蛋白的制备
公开(公告)号：US06686191B1
公开(公告)日：2004-02-03
申请号：US08532211
申请日：1995-09-22
申请人： William R. Alonso
发明人： William R. Alonso
IPC分类号： C12N704
CPC分类号： A61L2/0088 , C07K16/065
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.
摘要翻译：降低由抗体溶液病毒灭活处理产生的抗补体活性（ACA）的方法，该方法包括使溶液与磷酸三烷基酯如磷酸三正丁酯和洗涤剂如胆酸钠接触，在条件足以基本上减少病毒活性，然后在受控的时间，pH，温度和离子强度条件下孵育溶液，使得抗补体活性降低到可接受的水平。在优选的实施方案中，将ACA降低至小于60CH50单位/ mL，在3.5至5.0的pH下孵育至少约10天，温度保持在2至50℃的范围内，并且溶液的离子强度小于约0.001M。

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