Explore the Agenda
8:00 am Morning Breakfast & Registration
8:55 am Chairs Opening Remarks
Advancing mRNA Formulation Strategies to Enhance Assembly Fidelity, Delivery Performance & CMC Control
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
9:30 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
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
10:30 am Morning Break
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
12:30 pm 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
1:00 pm Lunch Break
Expanding the Boundaries of Process Development Manufacturing Through Emerging Frontiers of mRNA-Based Modalities
2:00 pm Panel Discussion: Pushing the Frontiers of mRNA: Manufacturing, Analytics & Control Strategies for CAR-T, Gene Editing & Dark Genome Applications
As mRNA expands into CAR-T, gene editing, and dark genome–derived applications, existing manufacturing and analytical paradigms are being fundamentally challenged. This panel brings together experts to examine how RNA design, process control, and release strategies must evolve to support transient expression, non-canonical sequences, and highly specialised therapeutic use cases.
- Designing mRNA constructs for next-generation modalities, including CAR-encoding and dark genome-derived sequences, examining how transient expression, sequence complexity, and translation efficiency reshape expectations for manufacturability and control
- Defining fit-for-purpose analytical and release frameworks capable of verifying mRNA quality, potency, and delivery performance in the context of cell therapy batches, gene editing workflows, and novel genomic targets
- Identifying where current CMC and regulatory assumptions break down, and how developers can proactively de-risk programmes by adapting analytics, comparability strategies, and control concepts early
3:00 pm Expanding the mRNA Modality Landscape: Translating Early R&D Learnings into Scalable Process Development for Next-Generation RNA Therapies
- Mapping the current state of emerging mRNA modalities including saRNA, taRNA, and circular RNA to inform early process development decisions before CMC lock-in
- Identifying key R&D-stage considerations when working with novel RNA formats to de-risk downstream scale-up and manufacturing strategy
- Leveraging small-scale IVT and GMP-aligned raw material choices in early development to enable smoother transition into later-stage process development