As the mRNA field evolves beyond vaccines into novel modalities, delivery platforms, and therapeutic indications, the need for rigorous, phase-appropriate analytical and quality strategies has never been more critical. With regulatory expectations rising and new guidance emerging from EMA, USP, NIST, and FDA, development teams face growing pressure to deliver harmonized analytical frameworks that withstand regulatory scrutiny and support robust CMC submissions.

While pipelines mature, scientific and technical complexity continues to grow, from controlling dsRNA impurities and potency assay variability to scaling analytical methods for late-phase development and GMP readiness. As next-gen platforms such as circular and self-amplifying RNA enter the clinic, the industry must redefine what robust characterization, control, and compliance look like.

The 5th Annual mRNA Analytical Development & Quality Control Summit brings together the analytical, quality, CMC, regulatory, and process development leaders driving this evolution. Across three days, the community will unite to shape the next standard for mRNA analytics and QC, strengthening product understanding, accelerating development, and ensuring safer, more effective mRNA therapeutics reach patients faster.

View the event here.