Title : Evaluating the immunogenic impact of process impurities in mRNA vaccine production: Establishing integrated control strategies and specifications
Abstract:
The advent of mRNA vaccines has revolutionized the landscape of immunization, particularly highlighted during the COVID-19 pandemic. It is well known that the production process for these vaccines can introduce various impurities, such as endotoxins, double-stranded RNA (dsRNA), and residual proteins, which may influence the overall immunogenicity and efficacy of the final product and its LNP carriers. This talk aims to illuminate the immunogenic responses elicited by these process impurities as well as the LNP delivery systems with an eye towards effective integrated control strategy and phase appropriate specification setting. Thereby enabling the delivery of safe and effective vaccines for the global population.
