Your Roadmap for mRNA Process Development & Manufacturing with Optimized Purification, Process Analytics & Enhanced Formulation to Improve Cost-Effectiveness & Scalability into the Clinic & Beyond

Accelerate, Scale & Economize Your mRNA Process Development & Manufacturing

With BioNTech and Moderna advancing personalised cancer vaccine trials, CEPI backing rapid response platforms, and emerging innovations in saRNA, circRNA, and gene editing, the mRNA field is experiencing a new era of opportunity.

As the industry shifts from pandemic to long-term therapeutic promise, drug developers face mounting pressure to reduce production timelines, de-risk regulatory submissions, and scale robust, reproducible, and compliant mRNA platforms.

The 4th mRNA Process Development & CMC Summit returns as the world’s only flagship forum dedicated to overcoming bottlenecks from designer enzymes and IVT to purification and room temperature stabilisation - helping mRNA therapeutic and vaccine developers deliver safer and more effective mRNA drugs to patients.

With focused content spanning DNA material sourcing, dsRNA control, in-process analytics, next-gen formulations, digital twins, lyophilization, saRNA, and regulatory readiness, this is the only event where the entire mRNA manufacturing ecosystem comes together to drive real-world implementation and clinical impact.

Whether you're scaling up, building out analytical and CMC control strategies, or navigating evolving FDA expectations, this summit will arm you with the technical depth, regulatory clarity, and peer insights needed to produce mRNA drugs faster, smarter, and more confidently.

Join the mRNA power table with Sanofi, GSK, Moderna, AstraZeneca, CSL, BioNTech, CEPI, US Pharmacopeia, CureVac, and Editas Medicines, along with 175+ global experts to walk away with the ultimate mRNA manufacturing roadmap.

FULL EVENT GUIDE

mRNA & CMC Summit - Most Recent Brochure

What’s New for 2025?

New Modalities Expanding mRNA Scope

Explore cutting-edge applications in self-amplifying RNA , circRNA, and gene editing with Arcturus Therapeutics, Editas Medicines and CSL who will deep dive into how these modalities are reshaping CMC strategies and scaling challenges from preclinical to commercial stages.

Lab of the Future With In-process Analytics

Discover how leading companies including Moderna, Sanofi, GSK and MIT are leveraging AI-driven formulation modelling, process simulation, digital twins, and inline analytics to optimize mRNA quality, predict batch variability, and drive smarter process development decisions.

Brand-New Speaker Lineup & Powerhouse Insights

Hear cutting edge case studies from GSK, AstraZeneca, CEPI, CureVac, CSL, Editas Medicine, and Arcturus, sharing real-world strategies to improve upstream design, purification, stability, and regulatory compliance – to bring safer and more effective drugs to patients.

Exclusive CMC & Regulatory Strategy

Gain exclusive access to regulatory experts guiding mRNA’s future, with focused discussions on dsRNA ranges, personalized therapies, global comparability, and process change approval, helping you position your platform for both FDA confidence and commercial success.

2025 Expert Speakers Include:

Catherine Hoath - CEPI

Catherine Hoath

Regulatory Affairs Strategy Lead

CEPI

Diane Mcarthy - US Pharmcopeia

Diane McCarthy

Senior Director - Science & Standards

U.S. Pharmacopeia

Eric Yearley - CSL

Eric Yearley

Associate Director - Messenger Ribonucleic Acid & Analytical Development

CSL

Gilles Divita - Divincell

Gilles Divita

Chief Executive Officer

Divincell

Mark Geng - Moderna

Mark Geng

Director

Moderna

Markus Schweitzer - CureVac

Markus Schweitzer

Vice President - Technical Operations

CureVac SE

Matthew Schmidt - Merck

Matthew Schmidt

Director, Quality Assurance

Merck & Co

Shirisha Meda - BioNTech

Shirisha Meda

Associate Director

BioNTech

Who Attended In 2024?

Access the 3-day, dual-track agenda, expert speaker line-up and pre-conference day details

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