Optimise mRNA Quality with Advanced Analytics & Formulation
As mRNA modalities diversify, teams need smarter analytical frameworks and more adaptable formulation strategies to ensure stability, potency and clinical performance. This stream focuses on the innovations pushing the field forward — from ML‑driven LNP optimisation and modular formulation platforms to next‑generation analytical methods and quality attributes built for saRNA, circRNA and emerging payloads. With insights from FormulAIte, the European Commission Joint Research Centre, Leiden University and Fraunhofer, you’ll learn how to design formulation and analytical systems ready for the next wave of mRNA therapeutics.
Essential Insights to Elevate mRNA Formulation & Analytical Strategy:
9:00 am Accelerating LNP Formulation Design Using Machine Learning: From Trial-and-Error to Data-Driven Optimisation
- Applying machine learning to LNP formulation design to systematically identify optimal ionisable lipids, compositions, and formulation technologies beyond traditional empirical screening
- Integrating formulation, microfluidics, and biological readouts into data-driven workflows, enabling faster iteration and more informed decision-making during early LNP development
- Reducing formulation development timelines while improving robustness, outlining how ML-guided approaches can support scalable, adaptable LNP strategies as mRNA modalities diversify
10:00 am Re-Engineering Lipid Nanoparticles for Emerging mRNA Payloads: Structural & Biological Design Considerations
- Examining how LNP internal structure and lipid composition govern stability, biodistribution, and immune interaction, and why these relationships become increasingly critical as payloads extend beyond conventional mRNA
- Adapting LNP architectures to accommodate new and mixed cargoes, including selfamplifying RNA and non-RNA payloads, while preserving functional performance in biologically relevant systems
- Investigating how small formulation choices influence biological behaviour, including immune response and in vivo performance, even when core components remain unchanged
11:30 am Building Modular & Automated Formulation Platforms for Scalable mRNA Drug Product Development
- Designing modular formulation and downstream processing units, including microfluidic mixing and tangential flow filtration as an inline purification module, to support adaptable, continuous mRNA drug product workflows
- Embedding process analytical technologies (PAT) directly into formulation operations, leveraging inline DLS as a dedicated PAT module alongside nano-analytics to enable real-time monitoring and control of LNP quality attributes
- Integrating automation and AI-driven optimisation across formulation workflows, accelerating development while maintaining flexibility across payloads, materials, and delivery system architectures
2:00 pm Analytical Readiness for mRNA therapeutics: Defining, Measuring & Assessing Quality
- Defining fit-for-purpose critical quality attributes (CQAs) for mRNA drug substance and drug products to support consistent quality assessment as programmes progress from early development into the clinic
- Comparing established and emerging analytical technologies used to assess mRNA therapeutics quality and batch consistency to highlight practical strengths, limitations and areas of divergence across current industry practice
- Identify gaps in analytical technologies for quality assessment of mRNA therapeutics
Innovators Driving Breakthroughs in RNA Formulation & Quality Assessment:
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.
Explore the Full Event Guide
- NEW: 5 World-Leading Regulatory Experts
- NEW: 2 Exclusive AI, Automation & Continuous Purification Workshops
- 12+ Case Studies on Novel mRNA Production Strategies
- 8+ Hours of Dedicated Networking
- 24 Premier Process Development, Quality & CMC Speakers
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