AN1306: QC Validation of a Polyvalent Polysaccharide Pneumococcal Vaccine

Molecular weight is a critical quality attribute for polysaccharide-based vaccines, since it impacts immunogenicity. SEC-MALS is ideal for determining the molecular weight of a monovalent polysaccharide antigen but is not suitable for QC testing of a polyvalent vaccine. This note describes the validation of Rate Nephelometry (RN), a QC-appropriate technique, against SEC-MALS.