Panel Discussion – Benchmarking Regulatory Harmonization for State-of-the-Art Analytical Methods, Qualification, and Validation
Time: 9:40 am
day: Day Two
With the expansion of mRNA-therapeutic applications at an accelerated pace, there is now a greater necessity to characterize mRNA to better understand their mechanisms of action and the performance systems. Novel analytical approaches, specifically within production, purification and high throughput automation needs to be developed to address design, test and analyse such systems. Validation of analytical methods for mRNA-based vaccines and therapeutics to improve quality control requires a deeper focus and will be explored in this panel discussion to combat the challenges and provide solutions for the future of analytical development
- How to better test, characterize and validate mRNA to assess drug substance quality and efficacy?
- Evaluating regulatory guidelines for cGMP, method validations and elemental impurities
- How to address scale-up challenges you might encounter while characterizing mRNA-based vaccines and therapeutics?