Glycoconjugate content quantification to assess vaccine potency: A simplified approach

• Published in: Biologicals Vol. 76; pp. 10 - 14
• Main Authors: Rech, Francesca, De Ricco, Riccardo, Giannini, Sara, Nompari, Luca, Paludi, Marilena, Berti, Stefania, Parlati, Chiara, Cianetti, Simona, Berti, Francesco
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01-04-2022
• Subjects: Bacterial vaccines; Carbohydrate antigens; Conjugate vaccines; Saccharide content; Vaccine potency; Saccharide content; Conjugate vaccines; Carbohydrate antigens; Vaccine potency; Bacterial vaccines
• ISSN: 1045-1056; 1095-8320
• DOI: 10.1016/j.biologicals.2022.02.004

Several glycoconjugate vaccines have been licensed or are currently in clinical development to prevent bacterial infections.
Here we report the development of a single analytical assay to quantify the conjugated saccharide content, as alternative to two separated total and free (unconjugated) saccharide assays used so far, for a quadrivalent conjugate vaccine containing meningococcal serogroup A polysaccharide (α-1,6-linked N-acetylmannosamine phosphate repeating unit partly O-acetylated at position C3 or C4) coupled with CRM197 protein.
The results confirm a high linear correlation among the two approaches (conjugated saccharide content vs. difference of total saccharide and free saccharide).
Conjugated saccharide content estimation is therefore demonstrated to be a suitable method to monitor the product quality of vaccines containing meningococcal serogroup A conjugate antigen, in the final filled presentation as demonstrated here and potentially on the bulk conjugate before formulation.