Exploring the Group B Streptococcus capsular polysaccharides: the structural diversity provides the basis for

Vittoria Pinto1, Francesco Berti1

  • 1Novartis Vaccines, Via Fiorentina 1, I-53100 Siena, Italy.

Insights

Nuclear Magnetic Resonance (NMR) spectroscopy can identify Group B Streptococcus (GBS) vaccine components. This method tracks manufacturing and can confirm vaccine identity for GBS capsular polysaccharide (CPS) types.

Area of Science:

  • Vaccinology
  • Analytical Chemistry
  • Microbiology

Background:

  • Carbohydrate-based vaccines are crucial for preventing bacterial infections like meningitis and pneumonia.
  • Group B Streptococcus (GBS) causes severe neonatal infections, yet no vaccine is available.
  • High-field Nuclear Magnetic Resonance (NMR) spectroscopy is effective for monitoring carbohydrate vaccine manufacturing.

Purpose of the Study:

  • To review structural differences in GBS capsular polysaccharide (CPS) types (Ia, Ib, II-VIII).
  • To explore the utility of unique NMR proton profiles for vaccine characterization.
  • To establish an identity assay for GBS monovalent vaccine bulks.

Main Methods:

  • Analysis of repeating unit structures of GBS CPS types using high-field NMR spectroscopy.
  • Identification of unique NMR proton profiles for each GBS CPS type.
  • Selection of well-resolved signals in anomeric, NeupNAc methylene (C3), and N-Acetyl regions.

Main Results:

  • Distinct NMR proton profiles were observed for different GBS CPS types.
  • Specific signals in the anomeric, C3 methylene, and N-Acetyl regions are suitable for identity assays.
  • A proof of concept demonstrated identity testing of a GBS CPS type Ia, Ib, III trivalent vaccine using selected anomeric signals.

Conclusions:

  • NMR spectroscopy provides unique fingerprints for GBS CPS types, enabling vaccine characterization.
  • The identified NMR signals can form the basis of a robust identity assay for GBS vaccines.
  • NMR-based identity testing is feasible for both monovalent and multivalent GBS vaccine formulations.