Aluminum Phosphate Vaccine Adjuvants
Composition and Size Analysis Using Offline and Inline Tools
Many human vaccines use aluminum-based adjuvants, such as aluminum phosphate (AlPO4), to boost the immune response. The interaction between the adjuvant and the antigen, which includes the antigen's physical adsorption, affects the vaccine's ability to generate an immune response. As a result, it is crucial to investigate the physicochemical properties of AlPO4, such as particle size and chemical composition, to ensure consistent vaccine product quality. Monitoring the adjuvant's properties throughout the manufacturing process, including raw materials and the intermediate and final product stages, helps ensure product quality.
Interaction between antigen and adjuvant or adsorption of antigen to adjuvant is critical for the effective adsorption. Particle size distribution of aluminum phosphate and adsorbed protein were examined by laser diffraction (LD) and Focused Beam Reflectance Measurement (FBRM) at line and inline respectively. Compositional analysis of aluminum phosphate was performed at line using FTIR and Raman Spectroscopy, and inline ATR probe were used to examine adsorbed protein suspension.
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About the Presenter
Marina Kirkitadze, Ph.D, MBA
Sanofi Pasteur
17 year experience with Sanofi Pasteur, the vaccine division of Sanofi group. She is the Head of Analytical Process Support and PAT Platform, Analytical Sciences Toronto. Marina's main focus is characterization of vaccine components, specifically, protein conformation and stability in solution and in adjuvanted form, analysis of raw materials, particle sizing technologies, and inline PAT applications. Her contributions went towards CMC section in eBLA application for Adacel, new manufacturing facility submission, Pentacel, and to Module 3 CTD of Hexaxim vaccine submission. Marina has published 36 manuscripts.
References
- Mei, C., Deshmukh, S. S., Cronin, J. T., Cong, S., Chapman, D. P., Lazaris, N., Sampaleanu, L., Schacht, U., Drolet-Vives, K., Ore, M. O., Morin, S., Carpick, B., Balmer, M. T., & Kirkitadze, M. (2019b). Aluminum phosphate Vaccine Adjuvant: Analysis of composition and size using Off-Line and In-Line tools. Computational and Structural Biotechnology Journal, 17, 1184–1194. https://doi.org/10.1016/j.csbj.2019.08.003
