Development and qualification of an automated capillary Western method for the identification of polysaccharide serotypes in pneumococcal conjugate vaccine (PCV).

Streptococcus pneumoniae bacterial infection causes mortality in both adults and infants. To mitigate the impact of the disease, several Pneumococcal conjugate vaccines (PCVs) have been manufactured for the U.S. market, including the recent approval of the 15-valent PCV Vaxneuvance™ from MSD. These vaccines demonstrate high efficacy for both the adult and pediatric dose. These PCVs contain multiple unique serotypes in the final, formulated vaccine product, and identifying a specific polysaccharide, in the presence of other serotypes, is a critical quality attribute that must be demonstrated through analytical testing. Here we describe the development and qualification of an identity assay using an automated capillary western system, called Simple Western, implementing a multi-valent system suitability sample (SSS) to determine individual polysaccharide components. The assay was optimized through rigorous analytical development and was successfully qualified for use in the clinical release of the PCV.