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 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.

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