Evaluating the immunogenic impact of process impurities in mRNA vaccine production: Establishing integrated control strategies and specifications

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.

Biography:

Dr. Jesse L. Kuiper, PhD is a Principal Scientist in the Vaccines Analytical Research and Development group in Merck Research Laboratories at the West Point, PA campus.  He holds a BSc degree in Chemistry and Biochemistry from the University of Michigan, Ann Arbor and a PhD in Chemistry from the University of Illinois at Urbana Champaign.  Jesse has been with Merck for over 18 years, with experience in analytical development for small molecule drug products, biopharmaceutics, and vaccines.  Jesse has extensive experience interacting with regulatory-CMC organizations across modalities and has recently served as the analytical lead for Dengue and mRNA programs.  Through his time at Merck, he has several patents and publications to his credit as well as three successfully marketed products.  He is currently a Development and Commercialization Lead for Merck mRNA vaccines.