The 3rd mRNA & CGT: CMC, Process Development and Manufacturing Summit is the leading European platform dedicated to advancing the development, scale-up, and GMP manufacturing of mRNA-based therapeutics and cell & gene therapies.Uniting specialists from biotech, pharma, CDMOs, regulatory bodies, and academia, the summit provides a high-level forum to dissect the technical, regulatory, and operational bottlenecks that define the future of advanced biologics.

Key Themes & Trends

As mRNA and CGT pipelines accelerate toward clinical and commercial readiness, the summit highlights the most pressing innovations in CMC strategy, process intensification, and manufacturability. Delegates will explore forward-looking topics such as:

• Modular, closed, and automated manufacturing platforms enabling scale-out and contamination control
• Next-generation LNP formulation and delivery systems for improved stability and biodistribution
• Advanced pDNA and IVT process engineering, reducing impurities and boosting productivity
• Digitization, real-time monitoring, and PAT deployment to improve process understanding, robustness, and release readiness

Current Challenges & Practical Solutions

The program focuses on industry-critical pain points and real-world approaches for accelerating development while maintaining regulatory compliance. Expert sessions will address how to:

• Maintain product quality, purity, and critical quality attributes (CQAs) through scale-up and scale-out
• Build and validate fit-for-purpose analytical methods for potency, identity, residuals, capping efficiency, and stability
• Meet evolving global regulatory expectations, including CMC dossier maturity, control strategies, and QbD implementation
• Manage comparability, process changes, lifecycle control, and tech transfer across sites and modalities
• Mitigate raw material variability, supply chain risk, and reliance on single-source suppliers

Networking & Collaboration

Beyond the technical content, #EmRNA provides a focused environment for cross-functional collaboration among process developers, analytical scientists, regulatory leaders, QA/QC experts, and manufacturing teams. Attendees gain a unique opportunity to benchmark their approaches, exchange best practices, and build partnerships essential to advancing mRNA and CGT products from early development to commercial launch.

Whether you work in CMC, process development, regulatory affairs, manufacturing science & technology (MSAT), or quality, the #EmRNA Summit delivers the insights, data, and strategic direction needed to stay ahead in this rapidly evolving therapeutic landscape