What Can You Expect in 2026?
Europe’s Premier Conference for End-to-End mRNA Process Development & CMC Success.
With the boom in mRNA activity and the ever-expanding therapeutic landscape in terms of modality, disease indication and delivery method, the demand on process and CMC teams to stay ahead of these ever-changing requirements is higher than ever.
With questions being raised on the impact of raw materials, impurity profiling, digitalisation and continuous manufacturing, the need for process and CMC innovation for mRNA therapeutics and vaccines has never been more important.
As Europe’s definitive and end-to-end mRNA forum, the 4th mRNA Process Development & CMC Summit returns to Frankfurt, and is committed to spotlighting the innovation pushing mRNA drugs towards successful regulatory submission. Showcasing process, manufacturing, CMC, analytical, quality, GMP, formulation, stability and regulatory perspectives, the 2026 program is built to empower drug developers like yourself to bring safer, high quality and effective mRNA drugs to patients faster.
Key focus areas include:
Regulatory and CMC Excellence
Navigating new draft guidelines and reference standards from EDQM, EMA, EU Pharmacopeia and Norwegian Medicine Product Agency to enhance compliance and regulatory clarity, and achieve successful regulatory submissions
Lab of the Future with In-Process Analytics
Discover how leading companies including Pfizer, BioNTech and FormulAIte, are leveraging AI-driven formulation modelling, process simulation, digital twins, and inline analytics to optimise mRNA quality, predict batch variability, and drive smarter process development decisions.
New Modalities Expanding mRNA Scope
Exploring cutting-edge applications in self-amplifying RNA , circRNA, and gene editing with Franuhofer who will deep dive into how these modalities are reshaping CMC strategies and scaling challenges from preclinical to commercial stages.
Bridging the Gap to Purification Prevention
Master how to optimise upstream raw materials and processes to build purity from the beginning and reduce the age-old downstream burden, to bring safer mRNA drugs to patients faster.
Join Europe’s end-to-end dedicated community for mRNA Process, CMC and Manufacturing excellence - where regulators, innovators, and technical leaders unite to set the benchmark for quality, cost-effectiveness, and clinical success.
Event Highlights
End-to-End Process Design
Explore how teams are building robust, scalable mRNA processes from DNA through IVT, purification and fill–finish to reduce late-stage rework and accelerate progression to clinic.
Scale-Up & Manufacturability
Learn how developers are translating lab-scale mRNA processes into GMP-ready workflows while maintaining yield, purity, and consistency across batches.
CMC Readiness by Design
Bridge process development and CMC strategy through phase-appropriate control strategies, critical quality attribute definition, and data-driven decision making.
Regulatory Alignment in Europe
Gain clarity on evolving EMA and MHRA expectations for mRNA products, including raw materials, process control, comparability, and lifecycle management.
Stability & Shelf-Life Strategy
Examine stability considerations across drug substance and drug product to support clinical supply, storage, and commercial readiness for diverse mRNA modalities.
Attending Companies Include