Advancing Analytical Rigor & Quality Control Standards for Novel mRNA Therapeutics

2026 Full Event Guide

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 continued to evolve beyond vaccines into novel modalities, delivery platforms, and therapeutic applications, the need for rigorous, phase‑appropriate analytical and quality strategies became more critical than ever. With regulatory expectations rising and new guidance emerging from the EMA, USP, NIST, and FDA, development teams faced increasing pressure to deliver harmonized analytical frameworks capable of withstanding heightened scrutiny and supporting robust CMC submissions.

As pipelines matured, scientific and technical complexity only intensified, from managing dsRNA impurities and minimizing potency assay variability to scaling analytical methods for late‑phase development and GMP readiness. With next‑generation platforms such as circular and self‑amplifying RNA entering the clinic, the industry was pushed to redefine what robust characterization, control, and compliance should look like.

Against this backdrop, the 5th Annual mRNA Analytical Development & Quality Control Summit united the analytical, quality, CMC, regulatory, and process development leaders driving this evolution. Over three days, the community came together to shape the next standard for mRNA analytics and QC-strengthening product understanding, accelerating development timelines, and helping ensure safer, more effective mRNA therapeutics reach patients faster.

It is a focused and specific conference, which is unlike any other big conference that has lots of topics to cover. You get enough chance to meet and talk to people at the conference.

Xue Zhou, Investigator, CSL

I highly recommend attending these specific conferences. It brings together top experts, showcases cutting-edge research, and provides great networking opportunities.

Dinesh Manvar, Associate Director, Sail Medicines

Round table discussions and networking lead to some very interesting discussions and great new connections.

Amy Piscareta, Associate Scientist II, Novo Nordisk

Your Peers Joined 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.

Download the 2026 Agenda

Explore The 2026 Full Event Guide

Exclusive Regulatory Workshop lead by US Pharmacopeia
10+ case studies on novel ADQC methods
Unrivalled Networking Opportunities
18+ World Class Expert Speakers
The world’s only forum exclusively focussed on Analytical Development & Quality Control

Download the Agenda