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Session 3 Track 3: Advancing the Analytical Toolbox for mRNA-Based Medicines
Session Chair(s)
Brian Doyle
Senior Director, CMC Development, Moderna, United States
As mRNA-based medicines expand into broader therapeutic and individualized applications, their unique analytical characterization requirements and challenges must be carefully considered. At the same time, emerging methodology and mRNA-specific regulatory guidance are enabling more sophisticated dialogue between developers and regulators regarding analytical control. In this session, perspectives on the current landscape of analytical capabilities for characterization of mRNA and lipid nanoparticles (LNPs) will be shared to motivate discussion on establishing appropriate and comprehensive control strategies.
Learning Objective : At the conclusion of this session, participants should be able to:- Discuss critical quality attributes relevant to mRNA-based medicines and applicable regulatory guidance
- Compare emerging analytical technologies and approaches for characterization of mRNA and LNPs
- Apply key principles for developing modality- and application-appropriate analytical control strategies
Speaker(s)
Sequencing-Based Strategies for Comprehensive Characterization of mRNA Therapeutics
Wayne Doyle, PhD, MBA
Head of Scientific Platforms and Strategy, Eclipsebio, United States
Speaker
Erin Tulip, MS
Director, Moderna, United States
Speaker
Brian Dooley, MPharm, MSc
Pharmaceutical Quality Senior Specialist, European Medicines Agency, Netherlands
Speaker
Robin Levis, PhD
Regulatory Chair of the ICH Q6 EWG, CBER, FDA, United States
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