Analysis of the Adsorbed Vaccine Formulations Using Water Proton Nuclear Magnetic Resonance-Comparison with Optical Analytics.

Abstract

To evaluate wNMR, an emerging noninvasive analytical technology, for characterizing aluminum-adjuvanted vaccine formulations. wNMR stands for water proton nuclear magnetic resonance. In this work, wNMR and optical techniques (laser diffraction and laser scattering) were used to characterize vaccine formulations containing different antigen loads adsorbed onto AlPO4 adjuvant microparticles, including the fully dispersed state and the sedimentation process. All wNMR measurements were done noninvasively on sealed vials containing the adsorbed vaccine suspensions, while the optical techniques require transferring the adsorbed vaccine suspensions out of the original vial into specialized cuvette/tube for analysis. For analyzing fully dispersed suspensions, optical techniques also require sample dilution. wNMR outperformed laser diffraction in differentiating high- and low-dose formulations of the same vaccine, while wNMR and laser scattering achieved comparable results on vaccine sedimentation kinetics and the compactness of fully settled vaccines. wNMR could be used to analyze aluminum-adjuvanted formulations and to differentiate between formulations containing different antigen loads adsorbed onto aluminum adjuvant microparticles. The resultsdemonstrate the capability of wNMR to characterize antigen-adjuvant complexes and to noninvasively inspect finished vaccine products.