Advancing Robust Process Optimization & Cost-Effective Scale-Up of mRNA Therapies

Optimize Process Development & CMC for mRNA Therapeutics & Vaccines Through Optimal Vendor Selection, Enhanced Purification and Efficient Process Analytics to Ensure Scalability of mRNA Medicine

With BioNTech and Moderna advancing personalised cancer vaccine trials, CEPI backing rapid response platforms, and groundbreaking innovations in saRNA, circRNA, and gene editing, the mRNA field entered a new era of opportunity in 2025.

As the industry continued its shift from pandemic response to long-term therapeutic promise, drug developers faced growing pressure to reduce production timelines, de-risk regulatory submissions, and scale robust, reproducible, and compliant mRNA platforms.

The 4th mRNA Process Development & CMC Summit successfully returned as the world’s only flagship forum dedicated to overcoming bottlenecks across the mRNA value chain from designer enzymes and IVT to purification and room-temperature stabilization empowering mRNA therapeutic and vaccine developers to advance safer, more effective mRNA drugs.

Featuring in-depth sessions on DNA material sourcing, dsRNA control, in-process analytics, next-gen formulations, digital twins, lyophilization, saRNA, and regulatory readiness, the summit brought together the entire mRNA manufacturing ecosystem to drive forward real-world implementation and clinical impact.

Whether scaling up, building analytical and CMC control strategies, or aligning with evolving FDA expectations, attendees gained the technical insights, regulatory clarity, and peer-driven strategies needed to accelerate mRNA drug development with greater confidence and precision.

The event convened global mRNA leaders from Sanofi, GSK, Moderna, AstraZeneca, CSL, BioNTech, CEPI, US Pharmacopeia, CureVac, and Editas Medicines, along with 125+ global experts to walk away with the ultimate mRNA manufacturing roadmap.

 

2025 Full Event Guide

Most Recent Brochure Cover

Organizations That Attended Include:

55400 Companies

What Was 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:

Diane Mcarthy - US Pharmcopeia

Diane McCarthy

Vice President, Global Biologics

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

Matthew Schmidt - Merck

Matthew Schmidt

director

Merck & Co

Shirisha Meda - BioNTech

Shirisha Meda

Associate Director

BioNTech

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

Lead Partner

Expertise Partner

Hosting Partner