Glycoconjugate content quantification to assess vaccine potency: A simplified approach

Area of Science:

• Vaccinology
• Analytical Chemistry
• Biotechnology

Background:

• Glycoconjugate vaccines are crucial for preventing bacterial infections.
• Current methods for quantifying saccharide content in conjugate vaccines are often separated assays for total and free saccharides.

Purpose of the Study:

• To develop a single, unified analytical assay for quantifying the conjugated saccharide content.
• To provide an alternative to existing separate total and free saccharide assays.
• To validate this assay for meningococcal serogroup A conjugate vaccines.

Main Methods:

• Development of a novel single analytical assay.
• Quantification of conjugated saccharide content in a quadrivalent conjugate vaccine (meningococcal serogroup A polysaccharide coupled with CRM197 protein).
• Comparison with traditional separate total and free saccharide assays.

Main Results:

• A high linear correlation was observed between the single assay's conjugated saccharide content and the difference between total and free saccharide measurements.
• The developed assay accurately quantifies conjugated saccharide content.

Conclusions:

• The single analytical assay is a suitable and efficient method for monitoring the product quality of meningococcal serogroup A conjugate vaccines.
• This method can be applied to both final filled vaccine presentations and potentially to bulk conjugates before formulation.