Who Counts As An Expert? Establishing Analytical Methods For Emerging mRNA-Based Therapies

The success of the first vaccines for SARS-CoV-2 demonstrated both the effectiveness of mRNA technology and the speed at which new vaccines could be developed using such a platform. The sudden emergence of this novel modality has necessitated the rapid development of analytical methodologies to ensure product quality and to meet the evolving regulatory requirements. This challenge is further complicated by the different nature of mRNA drug substance and the formulated drug product, often in the form of a lipid nanoparticle (LNP).

In this webinar, we describe the use of cutting-edge technologies to assess critical quality attributes of both mRNA drug substance and drug product.