Improving mRNA Characterization, Safety & Regulatory Adherence Through Robust Analytical Methods, Quality Control & Assay Development to Support mRNA Therapeutic & Vaccine Approvals
February 25-27, 2025 | Boston, MA
Uniting Large Pharma, Innovative Biotech & Leading Academics to Expedite Regulatory Adherence & Streamline Approval of Exceptional mRNA Medicines
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 & 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.
2025 Meeting CQAs
Extensive technical content covering the latest advancements in drug substance and product method development, validation and transfer. Including data driven presentations on:
Potency
Purity & Integrity
Stability
Impurity & Safety
Identity
Drug Product Composition
A new cohort of expert speakers and organizations presenting from the likes of Abogen Biosciences, Greenlight Biosciences, Gritstone Bio, Myeloid Therapeutics, Orna Therapeutics, Providence Therapeutics, Sail Biomedicines, Temple University, University of Geneva and Zipcode Bio
Expert-led workshops delving into the burning objectives of the analytical community, including controlling dsRNA and immunogenicity concerns, coalescing analytics for nucleic acid-therapeutics, and pioneering analytical methods and QC validation for novel mRNA gene therapies.
Expert Speakers Include
Erin Wierzbicki
Senior Manager - Global Chemistry Manufacturing Controls & Regulatory Affairs Vaccines
Pfizer
