METHOD FOR USING LIGHT SCATTERING IN REAL TIME TO DIRECTLY MONITOR AND CONTROL IMPURITY REMOVAL IN PURIFICATION PROCESSES
    4.
    发明申请
    METHOD FOR USING LIGHT SCATTERING IN REAL TIME TO DIRECTLY MONITOR AND CONTROL IMPURITY REMOVAL IN PURIFICATION PROCESSES 审中-公开
    在实时过程中使用光散射的方法直接监控和控制净化过程中的去除污染

    公开(公告)号:US20130303732A1

    公开(公告)日:2013-11-14

    申请号:US13850664

    申请日:2013-03-26

    Applicant: Amgen Inc.

    Abstract: The invention provides a method for controlling contaminants in biopharmaceutical purification processes by using light scattering and UV absorbance to establish a determinant. The invention makes use of multi-angle light scattering (MALS) and UV as a continuous monitoring system to provide information about the elution peak fractions in real-time instead of conventional pooling methods that rely on a predetermined percent UV peak max value to initiate the pooling process; regardless of product quality.

    Abstract translation: 本发明提供了一种通过使用光散射和UV吸光度来确定决定因素来控制生物药物净化过程中的污染物的方法。 本发明利用多角度光散射(MALS)和UV作为连续监测系统来实时提供关于洗脱峰分数的信息,而不是依赖于预定百分比的UV峰值最大值的常规汇集方法来引发 汇集过程; 不管产品质量如何。

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