With RNA technologies receiving the Nobel Prize two years running, we are witnessing the mRNA industry make great strides as optimized analytics, critical quality control methodology and robust assay development lead to efficient approvals and commercialization. However, developing, validating and transferring methods to demonstrate drug substance and product CQAs remains no easy feat, as knowledge gaps persist in phase appropriate potency assays, analyzing LNP payloads and novel cell-targeted delivery systems, controlling dsRNA, and navigating the global mRNA therapeutics and vaccine regulatory seas for approval in unmet patient need.
For the very first time, the 4th mRNA Analytical Development and Quality Control Summit will unite the tightly knit assay development, analytical and quality control communities, providing these technical teams with the means to secure regulatory submissions for 2025 and beyond.
For the very first time, the 4th mRNA Analytical Development and Quality Control Summit will unite the tightly knit assay development, analytical and quality control communities, providing these technical teams with the means to secure regulatory submissions for 2025 and beyond.