ABOUT EVENT
What You Missed at the 4th mRNA Analytical Development & Quality Control Summit
Growing in 2025 to host the analytical, assay development and quality control communities under one roof, the 4th mRNA Analytical Development & Quality Control Summit returned with 3 days of data-driven case studies to address your most prevalent pain points, including:
How to optimize potency assays for improved safety and toxicity testing
How to successfully purify and characterize mRNA in drug substance and mRNA-lipid nanoparticle
How to analyze LNP payload, encapsulation and distribution to ensure efficient mRNA delivery efficacy
How to optimize documentation and verification processes for platform methods
How to avoid common mistakes observed in regulatory submissions for analytical method validation
Uniting 100+ Senior Scientist, Directors and Heads of Analytical Development, Quality Control, Assay Development, CMC and Regulatory Affairs, this unrivalled forum was your opportunity to foster critical conversations and ensure the identity, safety and efficacy of new prophylactic and therapeutic RNA medicines to patients across the globe!
What You Missed:
Propelling the analytical toolbox for potency, stability, purity and integrity CQAs with GMP-compliant methodologies to expedite regulatory adherence with insights from Sanofi, Abogen Biosciences and BioNTech
Bolstering LNP formulations and novel cell-targeted delivery systems to enhance delivery efficacy and mRNA payload, and elicit a stronger, more durable response with Aera Therapeutics and Zipcode Bio
Strengthening regulatory submissions by overcoming immunogenicity and dsRNA bottlenecks and implementing phase-appropriate best practices with Sail Biomedicines and Orna Therapeutics
Supercharging assay analytical, quality and process development priorities to streamline the transfer and release of analytical methods and expedite regulatory compliant method qualification with Omega Therapeutics and Pfizer