Explore the Agenda
8:00 am Morning Coffee & Registration
8:55 am Chairs Opening Remarks
Characterizing mRNA Therapeutics to Define Integrity, Structure, & Analytical Reliability
9:00 am Lessons Learned for Building Fast & Reliable Analytical Development Strategies from Early Research to Phase I
- Key learnings from accelerating analytical development during the COVID-19 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
9:30 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
10:30 am From Bench to Bioinformatics: Harnessing RNA Sequencing as a Next-Generation Analytical Tool for mRNA Characterization & Q
Applying RNA-Seq to detect impurities, truncated transcripts, and dsRNA species 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
11:00 am Morning Break & Speed Networking
Our dedicated speed networking session is the perfect opportunity to have in-depth conversations and forge long-lasting connections with fellow technical experts working within mRNA Analytical Development & Quality Control.
Defining mRNA Functionality Through Assays that Accurately Reflect Biological Activity & Predict Clinical Performance
12:00 pm 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
12:30 pm Decoding RNA Quality with Sequencing-Based Analytics
- Compare manufacturing conditions using sequencing-based quality control
- Identify dsRNA impurities that drive off-target immune and safety risks
- Reveal potency-relevant insights from drug product uptake to translation
1:00 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
1:30 pm Lunch Break
Toxicity & Impurity Characterization in mRNA Therapeutics to Identify, Quantify & Remove Immunogenic Byproducts
2:30 pm Challenges in measuring dsRNA in drug substance samples
- Comparison of established methods to measure dsRNA
- Characterization of the dsRNA pool
3:00 pm Session details to be revealed
3:30 pm Advancing Impurity and Residual Analysis to Strengthen mRNA Product Quality and QC Readiness
- Developing and optimizing assays to detect and quantify critical impurities and residuals including dsRNA, proteins, and DNA in mRNA therapeutics
- Translating analytical rigor from development to QC to ensure reproducibility, compliance, and regulatory acceptance
4:00 pm Afternoon Break & Poster Session
Contribute to the conversation and share your cutting-edge research with like-minded AD & QC Experts. To present a poster, register your place and submit an abstract highlighting your breakthroughs. *Please visit the website for T&Cs for presenting a poster.
Embedding Robust Analytical Processes into GMP Environments to Secure Compliance & Enable Seamless AD-to-QC Transfer
5:00 pm Ensuring GMP Readiness Through Robust Analytical Strategy: Building Phase-Appropriate Methods to Support mRNA Quality and Purity
- Establishing a risk-based analytical control strategy to meet GMP requirements across development stages.
- Balancing flexibility and compliance: when to validate versus qualify analytical methods in early vs late phase.
- Overcoming common pitfalls in method transfer to QC labs and CDMOs while maintaining data integrity.
- Building feedback loops between analytical and manufacturing teams to pre-empt deviations and batch release delays.
5:30 pm Session details to be revealed
6:00 pm Ensuring Phase-Appropriate Method Readiness from AD Through QC to GMP
- How to establish phase-appropriate analytical methods that meet regulatory expectations despite limited resources and compressed development timelines.
- Strategies to adapt and validate assays for QC environments while maintaining analytical precision and CMC consistency.
- Approaches to coordinate cross-functional transfer from development to GMP to secure compliance and minimize rework at scale.