Explore the Agenda
8:30 am Morning Coffee & Registration
9:25 am Chairs Opening Remarks
Characterizing mRNA Therapeutics to Define Integrity, Structure, & Analytical Reliability
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 Next Generation RNA Medicines: STARR® Self-Amplifying mRNA Vaccines
- Differences between Arcturus sa-mRNA and approved mRNA vaccines
- EMA Approval Case Studies:
- Characterization of mRNA
- Fragments in Drug Substance
- Efficacy/tolerability of mRNA Fragments In Vivo
- Lipid Mass Balance
- Future Perspectives
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 Rapid and precise characterisation of RNA and ligands in LNPs via scatter-free absorbance
- Learn how scatter-free absorbance enables quantification of RNA and ligand concentration without dyes, surfactants or disruption of particles
- Understand how spectral deconvolution of UV spectra can simultaneously quantify payloads and ligands
- See how this new technique is being used to streamline RNA therapy development by massively simplifying RNA and antibody assays
1:40 pm Lunch Break
Toxicity & Impurity Characterization in mRNA Therapeutics to Identify, Quantify & Remove Immunogenic Byproducts
2:40 pm Advancing the toolset for mRNA/LNP characterization/platform method development
- New nucleases for more efficient MS-based sequencing of mRNA
- New wide pore SEC columns for QC of mRNA/LNP modalities
- New MS and compliance-ready informatics tools for mRNA sequencing/characterization
3:10 pm Advancing Impurity and Residual Analysis to Strengthen mRNA Product Quality & 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
3:40 pm Chairs Closing Remarks
3:45 pm Drinks Reception & 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