Explore the Agenda
8:00 am Registration & Light Breakfast
8:50 am Chair’s Opening Remarks
Replacing Fragmented Assays with NGS: A New Paradigm for Faster, Scalable mRNA QC
9:00 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 trace a minor deletion from the mRNA product back to the synthetic DNA template
9:30 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
10:00 am Morning Speed Networking Break
This networking session is your opportunity to get face-to-face with many of the leading voices and decision makers working in the mRNA Process Development & CMC field and establish meaningful business relationships to pursue for the rest of the conference
Track A: Research Scaling & IND-Enabling
Accelerating Scalable Manufacturing of Self- Amplifying & Circular RNA Modalities
11:00 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
11:30 am Innovation in Enzymes & Assays for mRNA Manufacturing
- Engineering T7 RNAP to improve IVT performance and address key mRNA manufacturing challenges
- Developing T7 RNAP mutants to reduce dsRNA impurity, lower cap analog usage, and improve RNA integrity for long mRNA sequences
- Building high-yield IVT systems and reliable dsRNA quantification methods to support mRNA process development and QC
12:00 pm 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
12:30 pm Unlocking the “True” Potential of Membrane-Based Chromatography — Solutions for the Next Generation of mRNA Manufacturing
- Purexa™ OdT membranes deliver advanced performance in mRNA purification, including higher binding capacity and faster processing.
- Purexa™ OdT membranes can successfully separate target mRNA species, regardless of size.
- Purilogics’ membrane technology has enhanced efficiency through reduction in cycle time and the reusability of membranes.
Track B: Clinical to Commercial
Process Optimization
Engineering Stable, Targeted LNP Systems to Enable Scalable & Accessible mRNA Therapeutics
11:00 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
11:30 am Seeing What Standard QC Misses: Sequencing- First Characterization for mRNA & Next-Generation RNA Modalities
- Direct RNA sequencing characterizes multiple core quality attributes in a single read including identity, integrity, and poly(A) length
- Next-generation sequencing resolves the mechanistic drivers of IVT RNA instability and impurities, including dsRNA and sequence-level degradation that bulk methods miss
- Integrating sequencing into quality control de-risks IVT RNA drug development, turning QC data into actionable feedback for sequence design and manufacturing
12:00 pm 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
12:30 pm Efficacy & Safety of Fujifilm’s Proprietary Ionizable Lipid for Liver Targeting & Liver De-targeting
- Template DNA design focusing on optimization of the 5’ and 3’ untranslated regions (UTRs) to enhance protein expression, conducted through a collaborative approach with partner companies
- Assessment of expression and safety for our proprietary ionizable lipid in IV in non-human primates
- Evaluation of a liver de-targeting formulation and its antibody conjugation for T-cell targeting
12:40 pm Lunch & Networking Break
Optimizing LNP Formulation & Manufacturing to
Enable Robust Preclinical Development & IND-Ready
mRNA Therapies
1:30 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
2:00 pm On-Demand Buffer Solutions for Next-Gen Therapies
- Build vs Buy considerations for reagent solutions
- Background on RUO/GMP buffer manufacturing capabilities to support R&D and CMC
- Case Study: Supporting US CDMO scale their operations with buffer outsourcing
2:10 pm Panel Discussion: Scaling LNP Workflows from Discovery to GMP and Beyond: Bridging Throughput, Robustness & Commercial Readiness
- How are teams successfully translating, 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?
2:40 pm Formulation & Process Development of Targeted LNPs for In Vivo T Cell & Hematopoietic Stem Cells Editing
- Establishing robust process characterization strategies for LNP formulation and fill-finish operations to enable consistent product quality through Phase II/III and commercial manufacturingSharing approaches to scale microfluidic mixing and downstream purification workflows while maintaining critical quality attributes including particle size, encapsulation efficiency, and potency
- Aligning analytical methods, comparability packages, and control strategies with evolving global regulatory expectations for commercial mRNA therapeutics and vaccines
Afternoon Poster Session
Explore cutting-edge research and emerging data from across the mRNA community. Connect with presenters, discuss findings, and uncover new ideas to advance your work.
*Submissions Available for Event Partners, Biopharma, & Academics. See website for full t&cs
Designing Scalable Manufacturing & CMC Strategies
for Emerging RNA & Advanced Therapies
1:30 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
2:00 pm Advancing mRNA Therapeutics with Targeted LNP Delivery: From Platform Innovation to Clinical Translation
- Broad mRNA application experience – Development experience across various mRNA applications provides an application-driven foundation for addressing diverse mRNALNP development challenges
- Targeted LNP platform for in vivo CAR – A robust tLNP platform combining antibody conjugation, formulation development, and cell-targeted delivery enables the development of next-generation in vivo CAR therapies
- From platform to clinical translation – case studies to demonstrate how integrated mRNA-LNP capabilities can help accelerate the translation of promising concepts from early research toward clinical development
2:10 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 characterization, 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
2:40 pm Scaling the Peak: Optimizing mRNA Capping for High-Yield Therapeutics
- Learn proven methodologies to streamline and tailor capping procedures to match your specific target product profile
- Review data on various capping solutions, and see how they impact yield, and critical quality attributes (CQAs) for both non-self-amplifying and self-amplifying RNA
- Gain actionable, hands-on tips for optimizing the capping reaction, including how to determine the ideal ratio of capping enzymes to mRNA for maximum stability and translation
Afternoon Poster Session
Explore cutting-edge research and emerging data from across the mRNA community. Connect with presenters, discuss findings, and uncover new ideas to advance your work.
*Submissions Available for Event Partners, Biopharma, & Academics. See website for full t&cs
From Impurity to Insight: Analytical & Purification Strategies to De-Risk mRNA Development & Enable Unprecedented CMC Progression
4:00 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 decision
- 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
4:30 pm Platform-Driven Process Development for Scalable RNA Therapeutics
- Build smarter: See how a platform-based framework can make mRNA process development more scalable, reproducible, and efficient
- Move faster: Explore modular design strategies that help reduce variability, streamline optimization, and smooth the path from research to GMP
- Advance with confidence: Learn how integrated process planning—from DNA template design through downstream processing—can reduce risk and support clinical progress
5:00 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