Advancing Analytical Rigor & Quality Control Standards for Novel mRNA Therapeutics

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.

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

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

Amy Piscareta, Associate Scientist II, Novo Nordisk

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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.

Explore The 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
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More Than a Meeting

80+

Attendees

18+

World-Class Speakers

10+

Case Studies

7+

Hours of Networking

3

Exclusive Workshops

1

Poster Session

Official Partners

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Attending Companies Include

GSK
Takeda
Tessera
AstraZeneca
US Pharmacopeia
Arcturus Tx
harvard medical school
BioNtech
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Explore the Agenda

Dive into cutting-edge mRNA ADQC, that are both phase-appropriate and aligned with early to late stage settings.

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Partner With Us

Showcase your technologies and services to decision-makers actively seeking and driving next-generation mRNA therapeutics.

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Join mRNA Leaders

Be part of the only forum uniting leading pharma, biotech, academia and regulatory experts