mRNA Vaccines: Quality Concepts In GMP IVT mRNA Development, Manufacturing & Analytics

mRNA vaccines have gained significant attention in recent years, largely due to their rapid deployment during the COVID-19 pandemic. While the core molecular technologies behind these therapeutics have been in development for decades, recent breakthroughs have propelled them from research labs to GMP clinical production and frontline patient care.

As this field evolves, quality systems, regulatory compliance, process controls, and analytical methods must keep pace to ensure the safety and efficacy of mRNA therapeutics. Although their production shares fundamental quality considerations with other biologics, the unique manufacturing processes and quality attributes of mRNA therapies continue to develop alongside advancements in technology and research.

This webinar will provide an overview of mRNA therapeutic design and manufacturing, emphasizing the importance of robust quality systems in GMP production. Topics will include raw material control, quality testing for release and stability, and analytical method development for bulk mRNA drug substances. Join us to explore key quality considerations in GMP IVT mRNA development and manufacturing.