| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 1221127 | Journal of Pharmaceutical and Biomedical Analysis | 2014 | 7 Pages |
•Repeating unit structures of GBS capsular polysaccharide type Ia, Ib, II–VIII.•Proton NMR profiles delineating the differences of GBS capsular polysaccharide repeating units.•Proof of concept of identity testing on a GBS CPS type Ia, Ib, III trivalent vaccine.
Carbohydrate-based vaccines constitute a potent tool for prevention of life-threatening bacterial infectious diseases like meningitis and pneumonia. Group B Streptococcus (GBS) is a major cause of neonatal sepsis and meningitis, particularly in infants born from mothers carrying the bacteria, and no vaccine is currently available. High-field Nuclear Magnetic Resonance (NMR) spectroscopy has been found to be an extremely robust tool for tracking the industrial process manufacturing of carbohydrate-based vaccines. Here we review the differences in the repeating unit structures of GBS capsular polysaccharide (CPS) type (Ia, Ib, II–VIII) yielding unique NMR proton profiles. All the profiles provided opportunities for selecting well resolved signals, in particular in the anomeric, the methylene protons at position C3 of N-acetyl-neuraminic acid (NeupNAc) and the N-Acetyl regions, which could be employed to develop an identity assay for monovalent vaccine bulks. Finally we reported a preliminary proof of concept of identity testing on a GBS CPS type Ia, Ib, III trivalent vaccine as blended bulks, based on the selection of one specific signal for each type in the anomeric region.
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