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    • 8. 发明申请
    • LIQUID INSULIN COMPOSITIONS AND METHODS OF MAKING THE SAME
    • 液体胰岛素组合物及其制备方法
    • US20120214964A1
    • 2012-08-23
    • US13032797
    • 2011-02-23
    • Ronald E. ZimmermanDavid John StokellMichael Patrick Akers
    • Ronald E. ZimmermanDavid John StokellMichael Patrick Akers
    • C07K14/62C12P21/06C12N15/63C12N1/21
    • A61K38/28C07K14/62C12P21/06
    • Disclosed herein are novel and improved preparations and methods for manufacturing substantially liquid preparations of recombinant human insulin API. The purified recombinant human insulin Active Pharmaceutical Ingredient (API) preparations are substantially free of by-products associated with the lyophilization and/or crystallization. The methods for manufacturing the substantially liquid recombinant human insulin API preparations are provided with optional steps for subjecting the recombinant insulin preparation to lyophilization and/or crystallization. Enhanced yield of recombinant insulin of greater purity are thereby provided according to the present invention. Highly purified formulations of recombinant human insulin of the API insulin preparations disclosed herein are also provided. Stably transformed E. coli cell banks (WCB) capable of expressing the recombinant human insulin are also provided.
    • 本文公开了用于制造重组人胰岛素API的基本液体制剂的新颖且改进的制剂和方法。 纯化的重组人胰岛素活性药物成分(API)制剂基本上不含与冻干和/或结晶相关的副产物。 制备基本上液体的重组人胰岛素API制剂的方法具有使重组胰岛素制剂进行冻干和/或结晶的任选步骤。 因此根据本发明提供了更高纯度的重组胰岛素的增加的产率。 还提供了本文公开的API胰岛素制剂的重组人胰岛素的高度纯化的制剂。 还提供了能够表达重组人胰岛素的稳定转化的大肠杆菌细胞库(WCB)。