Abstract
This chapter describes the analysis and quality control that is applied to subunit vaccines. Initially it is briefly reviewed the current status and major characteristics of this type of vaccines, laying the ground to understand what could go wrong during the different development phases from production to storage. On this basis are further addressed the requirements specified by the regulating agencies, the implications of each requirement and of the subsequent analysis, with more emphasis on Alum than emulsion-based formulations. The current knowledge on the impact that adsorption has on antigens is described as well as how to best study the adjuvant–antigen interaction. The chapter will also focus on how to attempt antigen desorption with considerations regarding the most common pitfalls. Final considerations will be deserved to the perspective and future direction that the field could face in the next few years, how the generated knowledge will be applied to improve vaccine characterization and development and how this will impact on the next generation of subunit vaccines.
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Pallaoro, M. (2015). Pharmaceutical Analysis and Quality Control of Vaccines. In: Foged, C., Rades, T., Perrie, Y., Hook, S. (eds) Subunit Vaccine Delivery. Advances in Delivery Science and Technology. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-1417-3_19
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DOI: https://doi.org/10.1007/978-1-4939-1417-3_19
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