METHOD FOR THE COMPARATIVE ANALYSIS OF PROTEIN PREPARATIONS BY MEANS OF NUCLEAR MAGNETIC RESONANCE
    8.
    发明申请
    METHOD FOR THE COMPARATIVE ANALYSIS OF PROTEIN PREPARATIONS BY MEANS OF NUCLEAR MAGNETIC RESONANCE 审中-公开
    通过核磁共振的蛋白质制备比较分析方法

    公开(公告)号:US20130069646A1

    公开(公告)日:2013-03-21

    申请号:US13520262

    申请日:2010-12-30

    IPC分类号: G01R33/465

    摘要: The invention relates to a method for the comparative analysis and control of the quality of a protein preparation by means of nuclear magnetic resonance (NMR) spectrometry. This method can be used to compare three-dimensional protein conformations in different protein preparations without requiring the samples to undergo any particular preparation. In particular, the method can be used to determine if a selected protein is in the same three-dimensional conformation in different protein preparations, if it is degraded in the formulation or if it is interacting with some of the excipients present. Specifically, the method can be used for the analysis and control of the quality of therapeutic compounds, particularly biodrugs or biosimilars, in different samples, without altering said samples.

    摘要翻译: 本发明涉及通过核磁共振(NMR)光谱法比较分析和控制蛋白质制剂质量的方法。 该方法可用于比较不同蛋白质制剂中的三维蛋白质构象,而不需要样品进行任何特定的制备。 特别地,该方法可用于确定所选择的蛋白质在不同蛋白质制剂中是否处于相同的三维构象,如果其在制剂中降解,或者如果它与存在的一些赋形剂相互作用。 具体地,该方法可用于分析和控制不同样品中治疗化合物,特别是生物药物或生物仿制药的质量,而不改变所述样品。