Alice Chen
Pfizer
The Impact of Product Matrices on the Stability of O-acetylated Capsular Polysaccharides in Pneumococcal Conjugate Vaccines
Streptococcus Pneumoniae is a bacterial pathogen that is responsible for severe invasive disease in humans. Licensed polysaccharide conjugate vaccines (PCVs) target the capsular polysaccharides of the bacterium, with different serotypes having distinct polysaccharide repeating units that can be decorated with additional chemical groups such as O-acetyl, phosphorycholine and glycerol-phosphate groups. For certain serotypes, preservation of these epitopes is crucial for maintaining capsular polysaccharide antigenicity, which can guide manufacturing or matrix design processes to ensure the stability of these labile groups. This study assessed the capacity of two distinct pH matrices to preserve O-acetyl group stability in two monovalent PCVs at various storage temperatures for up to 15 weeks. These data demonstrate that the pH 7 matrix leads to a substantial decrease in O-acetylation levels at high temperatures, whereas the pH 6 matrix preserves antigen stability across a broader range of storage conditions.
Streptococcus Pneumoniae is a bacterial pathogen that is responsible for severe invasive disease in humans. Licensed polysaccharide conjugate vaccines (PCVs) target the capsular polysaccharides of the bacterium, with different serotypes having distinct polysaccharide repeating units that can be decorated with additional chemical groups such as O-acetyl, phosphorycholine and glycerol-phosphate groups. For certain serotypes, preservation of these epitopes is crucial for maintaining capsular polysaccharide antigenicity, which can guide manufacturing or matrix design processes to ensure the stability of these labile groups. This study assessed the capacity of two distinct pH matrices to preserve O-acetyl group stability in two monovalent PCVs at various storage temperatures for up to 15 weeks. These data demonstrate that the pH 7 matrix leads to a substantial decrease in O-acetylation levels at high temperatures, whereas the pH 6 matrix preserves antigen stability across a broader range of storage conditions.
