5th mRNA Analytical Development and Quality Control Summit

As the mRNA field evolves beyond vaccines into diverse modalities, delivery systems, and therapeutic areas, analytical rigor has never been more critical. With the FDA intensifying scrutiny on CMC packages and new draft guidelines emerging from the EMA, USP, NIST, and FDA, the call for harmonized, phase-appropriate analytical and quality control strategies is needed now more than ever.
 
mRNA pipelines are maturing, but complexity continues to grow - from dsRNA impurities and potency assay variability to scaling analytical methods for GMP readiness. As the field faces increasing regulatory expectations and new modalities like circular and self-amplifying RNA enter the clinic, the industry must redefine what analytical excellence looks like.
 
This summit will unite the analytical, quality, and regulatory leaders driving this transformation to build a new standard for mRNA characterization, control, and compliance.