Development of a New Solid-Phase Extraction Base Method for Free Saccharide Content Estimation of Meningococcal Conjugate Vaccines

Riccardo De Ricco; Francesca Rech; Valeria Onnis; Salvatore Sanna Coccone; Giusy Scalia; Cristina Marcozzi; Massimiliano Gavini; Sara Beni; Sara Giannini; Luca Nompari; Chiara Parlati; Claudia Magagnoli; Simona Cianetti; Francesco Berti

doi:10.1021/acsomega.2c04013

Development of a New Solid-Phase Extraction Base Method for Free Saccharide Content Estimation of Meningococcal Conjugate Vaccines

ACS Omega. 2022 Oct 27;7(44):39875-39883. doi: 10.1021/acsomega.2c04013. eCollection 2022 Nov 8.

Affiliation

¹ Technical R&D, GSK, Via Fiorentina 1, Siena 53100, Italy.

Abstract

GlaxoSmithKline (GSK) is currently developing a fully liquid presentation to ease the administration of the licensed quadrivalent conjugate vaccine (Menveo) against meningococcal serogroup A, C, W, and Y (MenACWY) infections. Herein, we report a new method for determining the free saccharide (FS) content of CRM₁₉₇-MenACWY conjugated antigens, with the aim of improving accuracy and reproducibility. Mathematical models have been used to support technical knowledge in reducing the need for experimental development. This results in an improved, faster, and platform-based technique for FS separation with one single pretreatment applicable to all antigens of the multivalent meningococcal vaccine.