DAY ONE
Wednesday, February 26, 2025
7:30 am Check-In & Light Breakfast
8:20 am Chair’s Opening Remarks
Maximizing Resolution & Sensitivity in Purity & Integrity Assays Through Advanced Analytical Techniques & GMP-Compliant Methodologies
8:30 am Innovative Approaches in LC-MS Analysis of mRNA Therapeutics & Vaccines
Synopsis
- Method optimization for rapid and reliable mRNA integrity and sequence assessment
- Covering the benefits of intact and conventional bottom-up techniques for mRNA analysis
- Highlighting recent advances in enhancing method sensitivity for impurity detection
9:00 am Pushing the Limits of IP-RP Liquid Chromatography for Characterizing Integrity of Large mRNA
Synopsis
- Discussing a comprehensive study of 13 different ion-pairing reagents to assess the integrity of large mRNA
- Evaluating of the type, concentration and combination of ion-pairing agents, along with pH and temperature, for successful mRNA analysis
- Developing an optimized method analyzing mRNA molecules ranging from 1 to 6000 nucleotides in length
*New Data*
9:30 am Optimization & Implementation of a Capillary Gel Electrophoresis Method for Analysis of mRNA Integrity
Synopsis
- Developing and optimizing of a CGE method for routine analysis of drug substance and drug product samples for mRNA integrity
- Effectively implementing and qualifying the optimized method at a CDMO partner
- Stability monitoring of mRNA integrity with CGE
*New Data*
10:00 am Session Reserved for SCIEX
10:30 am Morning Break & Speed Networking
Synopsis
Our speed networking session is the ideal opportunity to get face-to-face time with many of the brightest minds working to develop safe and efficient mRNA medicines. Introduce yourself to the attendees that you would like to have more in-depth conversations with, benchmark against industry leaders, and establish meaningful business relationships that you can pursue for the rest of the conference and beyond
Advancing Precise Potency Assays to Optimize Product Quality, Efficacy & Regulatory Adherence for Efficient & Expeditious Approval
11:30 am Advancing Potency Assay Development & Optimization for Circular RNABased Therapeutics
Synopsis
- Designing and selecting an appropriate potency assay format for circular RNA-based therapies
- Developing and optimizing assay components to ensure accurate potency measure
- Characterizing the assay to ensure quality control compliance and streamline method validation
12:00 pm Panel Discussion: Navigating the Phase Appropriate Regulatory Prospective & Expectations of Potency Assays to Meet CQAs & CPIs to De-Risk Regulatory Submissions
Synopsis
- What is the phase appropriate expectation for potency assays? Protein expression versus activity-based methods
- What is the feedback on potency assays when using cell lines that do not match the site of indication?
- Debating the need to measure the potency of each component or drug substance of an mRNA-LNP, compared to just formulated drug product itself
12:30 pm Session Reserved for Waters Corporation
1:00 pm Lunch & Networking Break
Exploring Novel Advances in the Analytical Toolbox to Permit the Efficient Release & Commercial Approval of mRNA Vaccines & Therapeutics
2:00 pm mRNA Characterization: From 5’Cap to 3’ Poly(A) Tail
Synopsis
• Providing an overview of current analytical methods that have been used in the characterization of RNA quality, identity, and integrity
• Exploring the advantages and limitations from several analytical techniques
• Deep diving to analytical methods in the measurements of capping efficiency, poly A tail analysis
2:30 pm Session Reserved for Agilent
2:40 pm Identification of Major Impurities & Thermal Degradation Fragments of mRNA Drug Substances
Synopsis
- What type of impurities in mRNA drug substances and its thermal degradation products, methods including NGS sequencing, CE and more?
- Where is the potential degradation sites in mRNA and the effect from metal ions?
- Improving the stability of mRNA drug substances and its formulation
*New Data*
3:10 pm Afternoon Networking Break
Bridging Analytical, Quality & Assay Development Priorities to Meet GMP Guidelines for Faster mRNA Drug Approvals
4:10 pm Roundtable Discussion: Invigorating QC-Friendly Practices & Workflows to Improve the Transfer of Analytical Methods & Expedite Regulatory Compliant Method Qualification
Synopsis
- Determining the phase-appropriate readiness of an analytical methods for method transfer and QC qualification
- Assessing fitness for use, key quality parameters, and method robustness to streamline and de-risk qualification
- Optimizing mRNA assays for scalability and consistency in quality control operations
4:40 pm Flow-NMR as a Process-Monitoring Tool for mRNA IVT Reactions
Synopsis
- Tracking component NTP consumption kinetics and overall stoichiometry to facilitate optimization of IVT reaction
- Providing reference NMR method to support orthogonal PAT development for IVT reaction monitoring
- Optimizing process design and manufacturing costs by limiting expensive reagents