Application of NMR spectroscopy to derive in-depth characterization of structure and dynamical properties of biomolecules is well established nowadays in many laboratories. Most of these methods rest on the availability of protein labeled with stable isotopes like 13C and 15N. In this report examples are presented on the application of NMR spectroscopic methods to characterize biopharmaceutical proteins in cases no isotope labeled material are available. This is typically found in protein samples used in the development of formulations and production processes. Another important focus of this report is the application of NMR methodology in the field of counterfeit drugs of biologicals and biosimilars. Especially here, NMR does offer relevant structural and quantitative data due to the high versatility of the NMR equipment. An excurse regarding the high medical relevance for a detailed spectroscopic analysis of counterfeits will be presented.

中文翻译：

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生物学的蛋白质NMR：为开发和上市产品提供分析支持。

如今，在许多实验室中，利用核磁共振波谱法得出生物分子的结构和动力学特性的深入表征已广为人知。这些方法大多数都依赖于用稳定同位素如13C和15N标记的蛋白质的可用性。在本报告中，举例说明了在没有同位素标记材料的情况下应用NMR光谱法表征生物制药蛋白的方法。这通常在配方开发和生产过程中使用的蛋白质样品中发现。本报告的另一个重要重点是NMR方法在生物制品和生物仿制药假药领域的应用。特别是在这里，由于NMR设备的多功能性，NMR确实提供了相关的结构和定量数据。