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Protein NMR of biologicals: analytical support for development and marketed products

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Abstract

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.

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Acknowledgements

We acknowledge A. Genini, P. Goldbach, B. Gsell, A. Pappenberger (all Roche Basel) and A. Adler (Roche Penzberg) for support of the preparation of samples investigated and M. Binder (Roche Basel) for support with data acquisition.

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Authors and Affiliations

  1. Roche Pharmaceutical Research & Early Development, Lead Discovery, Roche Innovation Center Basel, Basel, Switzerland

    Fabio Casagrande

  2. Roche Pharmaceutical Quality Control for Commercial Bulk Products, Complaints and Counterfeits Group, Kaiseraugst, Switzerland

    Klara Dégardin

  3. Roche Pharmaceutical Research & Early Development, Pre-Clinical CMC, Roche Innovation Center Basel, Basel, Switzerland

    Alfred Ross

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  1. Fabio Casagrande
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  2. Klara Dégardin
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Correspondence to Fabio Casagrande.

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Casagrande, F., Dégardin, K. & Ross, A. Protein NMR of biologicals: analytical support for development and marketed products. J Biomol NMR 74, 657–671 (2020). https://doi.org/10.1007/s10858-020-00318-w

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