Explore the Agenda
8:00 am Morning Coffee & Registration
8:25 am Chairs Opening Remarks
Delivery & LNP Functionality in mRNA Therapeutics to Strengthen Characterization, Precision & Standardization
8:30 am Single Particle Characterization to Guide LNP Pre-Formulation for Emerging mRNA Modalities
- Applying single particle analysis to understand heterogeneity in LNP size, charge, and encapsulation efficiency, and why this matters for reproducibility
- Using particle-level insights to de-risk pre-formulation decisions in novel modalities (e.g., self-amplifying RNA, circular RNA, gene editing payloads)
- Linking particle attributes to critical quality attributes (CQAs) such as potency, immunogenicity, and stability to support early stage development
9:00 am Roundtable Discussion: Standardizing Potency & LNP Characterization for In-Vivo Gene Editing mRNA
- Define phase-appropriate potency strategies for editor mRNA payloads to generate data regulators will trust across IND through late stage
- Align LNP single-particle and bulk characterization readouts to improve cross-site comparability and decision-making
- Prioritize release and stability assays that balance scientific depth with QC practicality to accelerate clinical readiness
9:30 am Advancing mRNA Stability Studies to Improve Assay Comparability & Regulatory Confidence
- Investigating how mRNA performs at different temperatures to strengthen reliability of stability studies
- Developing analytical strategies to detect degradation pathways and aggregation events to improve assay comparability
- Embedding robust stability assays into development workflows to reduce variability and protect submissions from regulatory challenge
10:00 am QC Confidence in mRNA Therapeutics: Agilent LC/MS Solutions for Endto- End Analytical Control
- LC/MS Analysis for QC: Agilent LC/MS workflows deliver rapid confirmation of 5′ capping, detection of poly(A) variants, and detailed sequence mapping with impurity identification using systems such as the 6545XT AdvanceBio LC/Q-TOF and 1290 Infinity III Bio LC.
- Comprehensive QC Strategy: Agilent integrates early checkpoints with various analytical methods to monitor critical quality attributes across the entire mRNA lifecycle, from IVT through formulation and release, ensuring regulatory compliance and product consistency.
- Fragment Analyzer and Orthogonal Techniques: Complementary tools deliver high-resolution nucleic acid analysis using parallel capillary electrophoresis (CE) to assess nucleic acid size and integrity, detecting incomplete or degraded RNA to support confidence in mRNA therapeutic quality.
10:10 am Morning Break
Analytical Development & Quality Control for Novel RNA Modalities to Overcome ModalitySpecific Characterization & Functionality Challenges
11:10 am Case Study: Driving Analytical Robustness & CMC Readiness for Efficient Development of Novel RNA Modalities
- Navigating unique analytical and regulatory challenges when developing novel RNA-based vaccines
- Designing phase-appropriate QC and analytical strategies that can adapt as novel modalities progress toward GMP readiness
- How learnings from novel platforms can inform broader industry best practices in analytical robustness and CMC submissions
11:40 am High-Quality Reference Standards Enable Accurate dsRNA Quantitation
- Accurate quantitation of double-stranded RNA (dsRNA) remains a persistent quality control challenge in mRNA production processes
- The reliability of dsRNA measurements is strongly influenced by the purity and base composition of the reference standards used to generate standard curves
- We demonstrate the performance of a suite of dsRNA reference standards containing both natural and chemically modified nucleotides
11:50 am Integrating Circular RNA & Virus-Like Particle Platforms: Building Analytical & CMC Frameworks for Next-Generation RNA Therapeutics
- Establishing quality and analytical control strategies to support circular RNA–VLP platform development from early R&D through scalable GMP manufacturing
- Characterizing encapsulation efficiency and RNA integrity across distinct delivery modalities to ensure comparability, consistency, and safety
- Designing robust CMC pathways that enable regulatory readiness and streamline technology transfer for novel RNA-based vaccine and therapeutic platforms
12:20 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.