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

• Published in: Journal of biomolecular NMR Vol. 74; no. 10-11; pp. 657 - 671
• Main Authors: Casagrande, Fabio, Dégardin, Klara, Ross, Alfred
• Format: Journal Article
• Language: English
• Published: Dordrecht Springer Netherlands 01.11.2020; Springer Nature B.V
• Subjects: Biochemistry; Biological and Medical Physics; Biological products; Biomolecules; Biopharmaceuticals; Biophysics; Counterfeit; Isotopes; Magnetic resonance spectroscopy; NMR; NMR spectroscopy; Nuclear magnetic resonance; nuclear magnetic resonance spectroscopy; Physics; Physics and Astronomy; Proteins; spectral analysis; Spectroscopy/Spectrometry; Stable isotopes; Structural analysis; Biosimilars; NMR; Higher order structure; Counterfeits; Biologicals
• ISSN: 0925-2738; 1573-5001; 1573-5001
• DOI: 10.1007/s10858-020-00318-w

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 13 C and 15 N. 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.