Streamlining Early to Late Phase Analytical Testing & Optimizing Quality Control for mRNA Vaccines & Novel mRNA Therapeutics to Improve Characterization of Your Drug Substance & Meet Evolving Regulatory Requirements
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.
Join Your Peers To:
Navigate Evolving Regulatory Expectations
Gain clarity on new guidance from EMA, FDA, NIST, and USP to strengthen analytical packages and minimize CMC pushback
Standardize and Harmonize AD/QC Workflows
Learn from GSK, CureVac, and CSL on bridging analytical development and QC to ensure global consistency and GMP readiness
Advance Potency and Characterization Assays
Hear from Moderna, BioNTech, and Sanofi on evolving potency assays across phases and the latest techniques for structural and functional integrity
Accelerate Innovation for Novel Modalities
Explore analytical and stability strategies tailored to circular, self-amplifying, and next-generation RNA platforms
This is your opportunity to join the world’s only forum exclusively dedicated to mRNA Analytical Development and Quality Control - where science, regulation, and collaboration come together to define the next chapter of analytical excellence in mRNA therapeutics and bring safer mRNA drugs to patients.
Attending Companies Include