Explore the Agenda
7:30 am Registration & Light Breakfast
8:20 am Chair’s Opening Remarks
Replacing Fragmented Assays with NGS: A New Paradigm for Faster, Scalable mRNA QC
8:30 am Replacing Fragmented Assays with NGS: A New Paradigm for Faster, Scalable mRNA QC
- Consolidation & Operational Efficiency: NGS is a robust, single-platform Multi-Attribute Method (MAM), capable of consolidating USP-recommended CQAs including Identity, Integrity, 5, Capping, and Poly(A) tail length into a single 4–8-hour workflow. By replacing fragmented, low-throughput orthogonal assays (CGE, HPLC, and MS), this approach significantly reduces analytical burden and operational complexity in CMC environments
- Superior Resolution through Single-Molecule Depth: NGS provides enhanced molecular resolution over bulk-averaging methods, resolving complex poly(A) heterogeneity and 5, truncations with >99%sequence accuracy
- Direct Impurity Traceability: NGS can traced a minor deletion from the mRNA product back to the synthetic DNA template
9:00 am Leveraging NGS to Enable Scalable QC & Process Control for Complex Multivariant mRNA Vaccines
- Exploring how NGS can consolidate multiple critical quality attributes into a single, data-rich analytical workflow for complex mRNA products
- Overcoming the QC and CMC challenges associated with 22-component multivariant RNA vaccines where traditional analytical methods struggle to assess integrity, identity & potency at scale
- Sharing lessons learned from implementing next-generation sequencing approaches for in-process control, release testing & regulatory readiness in next-generation mRNA vaccine development
9:30 am Morning Speed Networking Break
Track A: Research Scaling & IND-Enabling
Accelerating Scalable Manufacturing of Self- Amplifying & Circular RNA Modalities
10:30 am Overcoming CMC & Operational Challenges to Enable Successful saRNA Development
- Navigating key manufacturing challenges in saRNA development, including scalability, process robustness, and product quality considerations
- Evaluating and selecting the right CRO partners to support efficient development, tech transfer, and long-term program success
- Applying effective cross-functional project management strategies to streamline timelines, communication, and CMC execution across saRNA programs
11:00 am Presentation Details to be Realeased
11:30 am Enabling Safe & Effective Delivery of Self-Amplifying RNA – Overcoming Formulation & CMC Challenges from Preclinical to Clinical
- Understanding how the unique biology of self-amplifying RNA drives distinct delivery requirements, and why conventional LNP approaches may not directly translate
- Exploring tissue-localized formulation strategies to optimize potency, dose efficiency and clinical performance of saRNA therapeutics and vaccines
- Overview of clinical data and platform insights into CMC readiness, including how to navigate manufacturing complexity and leverage early clinical data to inform scalable delivery approaches
12:00 pm Presentation Details to be Released
Track B: Clinical to Commercial
Process Optimization
Engineering Stable, Targeted LNP Systems to Enable Scalable & Accessible mRNA Therapeutics
10:30 am Advancing LNP Stability, Storage & Supply Chain Strategies for Commercial mRNA Products
- Optimizing LNP composition and excipient selection to improve long-term stability, reduce cold chain burden, and support global product distribution
- Exploring real-world lessons from clinical and commercial manufacturing around storage conditions, shipping logistics, and maintaining product integrity at scale
- Discussing integrated CMC strategies to support lifecycle management, tech transfer, and commercial readiness for next-generation mRNA and LNP-enabled therapeutics
11:00 am Presentation Details to be Released
11:30 am Engineering Targeted LNP Platforms for Scalable & Accessible mRNA Vaccine Development
- Exploring formulation strategies for incorporating targeting moieties into lipid nanoparticle platforms to enhance dendritic cell uptake and improve vaccine potency at lower doses
- Sharing stability optimization approaches for targeted LNP systems, including considerations around lipid degradation, storage stability, and formulation robustness during development
- Discussing how early CMC and manufacturing decisions can support scalable, cost-effective mRNA vaccine production for global access and deployment in low-resource settings
12:00 pm Presentation Details to be Released
12:10 pm Lunch & Networking Break
Optimizing LNP Formulation & Manufacturing to
Enable Robust Preclinical Development & IND-Ready
mRNA Therapies
1:00 pm Building Semi-Automated High-Throughput LNP Workflows to Accelerate Preclinical mRNA Development
- Developing scalable, semi-automated workflows to streamline mRNA and LNP production from plasmid DNA through to encapsulated product for rapid preclinical evaluation
- Leveraging liquid handling systems and high-throughput screening platforms to accelerate formulation optimization while maintaining material quality suitable for in vivo studies
- Sharing lessons learned from translating mRNA and LNP processes across bench-scale, GMP manufacturing, and miniaturized automated screening systems
1:30 pm Presentation Details to be Released
1:40 pm Panel Discussion: Scaling LNP Workflows from Discovery to GMP and Beyond: Bridging Throughput, Robustness & Commercial Readiness
Key questions include:
- How are teams successfully translating high-throughput, discovery-stage LNP workflows into robust, GMP-ready processes without compromising product quality?
- Where do current LNP workflows break when moving from preclinical into clinical and commercial scale – and how can these gaps be addressed early?
- What needs to change today to ensure LNP platforms remain scalable, reproducible, and cost-effective as products move toward global commercial supply?
Designing Scalable Manufacturing & CMC Strategies
for Emerging RNA & Advanced Therapies
1:00 pm Viral vs Non Viral Delivery: Opportunities to Improve Activity, Manufacturing & Regulatory Paths
- The next evolution gene editing, gene writing and gene insertion have increased interest in evaluating viral and non‑viral delivery platforms, including evolving criteria around scalability, safety, and clinical applicability
- Key sources of manufacturing complexity and variability across modalities, and how these impact development timelines and operational models
- How the delivery landscape has evolved — and what this means for integrating mRNA and emerging approaches alongside established platforms
1:30 pm Presentation Details to be Released
1:40 pm Durable RNA Vaccines & Therapies: Unlocking the Manufacturing & CMC Potential of Next-Generation Self- Amplifying RNA Platforms
- Exploring how self-amplifying RNA (saRNA) platforms can reshape manufacturing economics through lower dose requirements, increased protein expression, and enhanced durability compared with conventional mRNA approaches
- Addressing the unique CMC and scale-up considerations associated with saRNA development, including construct complexity, analytical characterisation, stability optimization, and process consistency at larger scales
- Designing platform-ready manufacturing strategies that enable flexible translation across vaccines and therapeutics while maintaining speed, quality, and commercial scalability
- Evaluating how next-generation RNA modalities may influence future supply chain demands, CDMO partnerships, and regulatory expectations as the industry moves beyond first-generation mRNA systems
2:20 pm Afternoon Networking Break
3:20 pm Roundtable Discussion: Translating Potency into Process Insight: Integrating Analytical Readouts to Strengthen mRNA CMC Decision- Making
- Examining how potency assays can evolve from endpoint measurements to actionable tools, enabling deeper process understanding and more confident development decisions
- Addressing challenges in maintaining meaningful, phase-appropriate potency readouts as mRNA products progress from early development through IND-enabling workflows
- Exploring strategies to integrate analytical data with process parameters, supporting improved product consistency, faster iteration, and more robust CMC progression
4:00 pm Presentation details to be Released
4:30 pm Advancing Multi-Attribute Analytical Strategies to Accelerate mRNA Process Development & Product Quality Control
- Exploring how multi-attribute analytical approaches can consolidate identity, purity, integrity & dsRNA assessment into streamlined, data-rich workflows for mRNA development
- Evaluating emerging technologies including sequencing-based and chromatographic assays to improve process understanding while reducing analytical complexity and turnaround time
- Discussing how sensitive, high-throughput analytical platforms can support faster platform development, enhanced product quality & accelerated progression from discovery to IND-enabling studies