Use of NMR as an analytical tool in the process development of conjugate vaccines against Haemophilus influenzae type b (Hib) and meningococcal serogroup A (MenA).

The native structure of the bacterial polysaccharide is the key immunogenic component of conjugate vaccines and antibodies raised against the polysaccharide structure are responsible for providing protection against the corresponding pathogen. The manufacturing process of conjugate vaccines is very complex and has various biological and chemical steps. It is important to monitor the process to ensure that the structural identity of the polysaccharide is maintained throughout the process. NMR spectroscopy can be used as a versatile analytical tool to monitor the structural integrity of the polysaccharide component from isolated polysaccharide to conjugate vaccine and for identifying different impurities generated during the process.