Explore the Agenda
7:30 am Morning Breakfast & Registration
8:25 am Chairs Opening Remarks
Advancing mRNA Formulation Strategies to Enhance Assembly Fidelity, Delivery Performance & CMC Control
8:30 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
9:00 am Roundtable Discussion: Translating LNP Drug Product CMC Learnings to Enable Novel Excipients in mRNA Formulations
- Identifying the key principles for advancing LNP drug products through clinical phases while maintaining flexibility for evolving modalities and indications
- Evaluating when and why to introduce novel excipients and ionisable lipids into LNP formulations to balance innovation with CMC and regulatory risk
- Managing drug product CMC across development stages to ensure manufacturability, comparability, and clinical progression of LNP-based mRNA therapies
- Aligning formulation strategy, excipient selection, and control approaches to support robust CMC packages without over-engineering early programs
9:30 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
10:00 am Morning Break
11:00 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
11:30 am Overcoming RNA Delivery Constraints with Silicon-Stabilised Hybrid Lipid Nanoparticles
- Introducing silicon-stabilised hybrid lipid nanoparticles (sshLNP) as a next-generation RNA delivery platform, combining organic lipid systems with bioabsorbable inorganic silicon to overcome stability and safety limitations of conventional LNPs
- Demonstrating how sshLNP architecture improves RNA stability, transfection efficiency, and tolerability, enabling more reliable delivery across challenging genetic targets and rare disease applications
- Translating delivery innovation into scalable therapeutic development, outlining how integrated bio-analytical capabilities and platform scalability, support rapid progression to clinic