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    • 3. 发明申请
    • METHOD FOR THE VERIFICATION OF THE REMOVAL OF VIRUSES TO VALIDATE FILTERS AND FILTERING PROCESSES
    • 用于验证去除病毒以验证过滤器和过滤过程的方法
    • US20080213753A1
    • 2008-09-04
    • US12047470
    • 2008-03-13
    • Hartmut HENNINGOscar-Werner ReifKlaus TarrachRobert Zeidler
    • Hartmut HENNINGOscar-Werner ReifKlaus TarrachRobert Zeidler
    • C12Q1/70
    • C12N7/00C12N2750/14051
    • Disclosed is a method for verification of the removal of viruses to validate filters, filtering processes, physical and chemical inactivation processes, or adsorptive removal processes in predefined process conditions that are simulated on a small scale. According to said method, viruses are cultured in suitable cell lines in a first step, a virus suspension is obtained after solubilizing cells in a second step, the virus suspension obtained is added in a third step to a protein solution that is to be analyzed, and the virus-containing protein solution is filtered through the filter that is to be validated, and the removal of viruses is then analyzed in a fourth step. The virus suspension is first processed via a membrane adsorber following step two, the viruses being bonded to the membrane adsorber and contaminants being removed with the aid of a detergent buffer solution, while the bonded, purified viruses are eluted from the membrane adsorber area and are added to the protein solution that is to be analyzed as a concentrated virus suspension in step three.
    • 公开了一种验证病毒去除以验证过滤器,过滤过程,物理和化学灭活过程或在小规模模拟的预定义工艺条件下的吸附去除过程的方法。 根据所述方法,在第一步骤中,将病毒在合适的细胞系中培养,在第二步溶解细胞后获得病毒悬浮液,将获得的病毒悬浮液添加到待分析的蛋白质溶液中, 并通过要验证的过滤器过滤病毒蛋白质溶液,然后在第四步骤中分析病毒的去除。 首先在步骤2之后通过膜吸附器处理病毒悬浮液,病毒结合到膜吸附器上,借助于洗涤剂缓冲溶液除去污染物,而结合的纯化病毒从膜吸附区域洗脱出来,并且是 添加到在步骤3中待浓缩的病毒悬浮液分析的蛋白质溶液中。