Chapter 13 - One- and Two-Dimensional NMR Techniques for Biopharmaceuticals

Abstract

Nuclear magnetic resonance (NMR) spectroscopy is routinely used by chemists to assist in the identification of the atomic structure of their molecule of interest. However, although NMR spectroscopy is a widely used analytical tool, the application of NMR techniques in the biopharmaceutical industry has been limited by the perception that the approach is too complex or insensitive. In order to illustrate the utility of the technique, we provide a description of the physical basis of NMR, the instrument design and the factors that impact the data. These concepts are then demonstrated using practical examples of the application of NMR to biotherapeutics. This chapter is intended for biologists and biochemists that have little or no formal training or knowledge in NMR spectroscopy. An overview of the important principles (without the use of mathematics) is laid out to provide the reader with the concepts needed to understand the types of information obtainable and the limitations and the advantages of NMR spectroscopy of biologics. The authors hope that a better understanding of NMR methods for biotherapeutic products will dissipate arguments against its adoption while helping to identify how NMR can contribute to a drug development program and the manufacturing process.