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首页> 外文期刊>Pharmaceutical Research >Monitoring Effects of Excipients, Formulation Parameters and Mutations on the High Order Structure of Filgrastim by NMR
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Monitoring Effects of Excipients, Formulation Parameters and Mutations on the High Order Structure of Filgrastim by NMR

机译:NMR监测辅料,配方参数和突变对非格司亭高阶结构的影响

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Purpose Filgrastim is the generic name for recombinant methionyl human granulocyte colony-stimulating factor (r-metHuG-CSF). It is marketed under the brand name Neupogen® by Amgen. Since this product has lost patent protection, many biosimilar versions have been approved or are in the process of filing for market authorization throughout the world. Here we show that NMR spectroscopy can be used to assess the three-dimensional structure of the active ingredient in the formulated approved product Neupogen®.
机译:目的Filgrastim是重组蛋氨酸人粒细胞集落刺激因子(r-metHuG-CSF)的总称。它由Amgen以Neupogen®品牌销售。由于该产品失去了专利保护,因此许多生物仿制药均已获批准或正在申请全球市场许可。在这里,我们表明,NMR光谱可用于评估已配制的批准产品Neupogen®中活性成分的三维结构。

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  • 来源
    《Pharmaceutical Research》 |2015年第10期|3365-3375|共11页
  • 作者单位

    Centre for Biologics Evaluation Biologics and Genetic Therapies Directorate Health Canada">(1);

    Centre for Biologics Evaluation Biologics and Genetic Therapies Directorate Health Canada">(1);

    Centre for Biologics Evaluation Biologics and Genetic Therapies Directorate Health Canada">(1);

    Centre for Biologics Evaluation Biologics and Genetic Therapies Directorate Health Canada">(1);

    Centre for Biologics Evaluation Biologics and Genetic Therapies Directorate Health Canada">(1);

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