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 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.
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