Vaccine Quality Ensured by High-Performance Anion-Exchange Chromatography with Pulsed Amperometric Detection.

Many important vaccines use bacterial capsular polysaccharides, or shorter polysaccharides or oligosaccharides, derived from the capsular polysaccharides, conjugated to protein. It is imperative that manufacturers understand the carbohydrate composition of these vaccines and deliver a product with a consistent polysaccharide or polysaccharide conjugate composition and content. High-performance anion-exchange chromatography with pulsed amperometric detection (HPAE-PAD) is a major technique used to understand the carbohydrate composition of these vaccines and ensure product quality. HPAE-PAD separates and detects carbohydrates without analyte derivatization. This paper describes the basics of the HPAE-PAD technique and then reviews how it has been applied to Haemophilus influenzae type b, pneumococcal, meningococcal, group B streptococcal, and Salmonella polysaccharide and corresponding conjugate vaccines.