1. INTRODUCTION AND SCOPE

This chapter describes the application of nuclear magnetic resonance (NMR) spectroscopy to the identity testing of bacterial polysaccharides used in vaccine manufacture. The identity of the saccharide component in polysaccharide and glycoconjugate vaccines should be confirmed at various stages of the manufacturing process, including bulk monovalent polysaccharide, blended polysaccharide bulk, activated polysaccharide (if isolated), bulk monovalent conjugate, blended conjugate bulks, and final fills. NMR is an appropriate method to confirm the identity of polysaccharides, although it is most useful for bulk monovalent polysaccharides and activated polysaccharides (if isolated). This chapter describes the use of NMR spectroscopy for this purpose, but alternative validated approaches may also be suitable.