Explore the Agenda
7:30 am Morning Coffee & Registration
8:25 am Chairs Opening Remarks
Characterizing mRNA Therapeutics to Define Integrity, Structure, & Analytical Reliability
8:30 am Lessons Learned for Building Fast & Reliable Analytical Development Strategies from Early Research to Phase I
- Â Key learnings from accelerating analytical development during the COVID-19Â vaccine era
- Establishing fit-for-purpose assays to enable rapid transition from research to clinical manufacturing
- Implementing flexible analytical frameworks to support novel mRNA modalities and vaccine programs
9:00 am Roundtable Discussion: Translating Complex mRNA Characterization Assays into QC-Ready Strategies to Reduce Downtime between Teams
How to adapt AD assays into validated QC workflows to ensure reproducibility across sites and manufacturing scales
How to overcome challenges of assay transfer, variability, and lack of reference standards to safeguard consistency and compliance
How to embed standardized characterization workflows to support smoother regulatory submissions, tech transfer and global comparability
9:30 am om Bench to Bioinformatics: Harnessing RNA Sequencing as a NextGeneration Analytical Tool for mRNA Characterization & Q
 Applying RNA-Seq to detect impurities, truncated transcripts, and dsRNA speciesÂ
that escape traditional assays
- Comparing sequencing against conventional integrity and potency assays to define regulatory-ready standards
- Establishing seamless workflows from sample prep to bioinformatics to bride wet lab and digital pipelines and accelerate decision-making
- Positioning sequencing-based analytics as a potential platform method for comparability, release, and long-term stability studies
10:00 am Morning Break & Speed Networking
Our dedicated speed networking session is the perfect opportunity to have in-depth conversationsÂ
and forge long-lasting connections with fellow technical experts working within mRNA AnalyticalÂ
Development & Quality Control
Defining mRNA Functionality Through Assays that Accurately Reflect Biological Activity & Predict Clinical Performance
11:00 am From Development to QC: Phase-Appropriate Validation & Reagent Qualification for Reproducible mRNA Assays
- Establish robust reference standards and qualified reagents early to enable long-term reproducibility across analytical sites
- Apply phase-appropriate validation to maintain flexibility in early development while ensuring regulatory readiness at later stages
- Control assay variability from IVT reagents, detection antibodies and instrumentation to safeguard data integrity and batch comparability
11:30 am Session details to be revealed
Reserved for Eclipse Bioinnovations
12:00 pm Establishing Core Endpoints That Truly Correlate with Biological Readouts to Validate mRNA Functionality
- Comparing in vitro, cell-based and engineered model systems to determine which assays should be standardized to best represent functional mRNA performance
- Differentiating between integrity, encapsulation, and total mRNA content to determine which attributes meaningfully correlate with biological activity
- Lessons learnt from CQAs that failed to predict immunogenicity or efficacy to streamline submission packages that prove mRNA functionality
12:30 pm Lunch Break
2:00 pm Adapting Analytical & QC Strategies for Emerging RNA Modalities to Ensure Robust Characterization & Release
-  How evolving RNA modalities like circular and self-amplifying RNA are reshaping analytical design and QC readiness
- Translating flexible R&D assays into GMP-compliant QC methods without compromising analytical sensitivity
- Balancing innovation and standardization to build adaptable yet regulator-ready analytical frameworks for next-generation RNA therapeutics
2:30 pm Building Characterization Assays to Support Early-Stage saRNA Development and QC Alignment
- Establishing characterization assays that define saRNA product quality and inform key CMC decisions in early development.
- Ensuring analytical consistency and data integrity when partnering with CROs and CDMOs for assay execution and method transfer.