Ensuring Critical Regulatory Alignment, Adopting Next-Generation Analytical Methods & Improving Characterization, Quality & Potency to
Safeguard the Commercial Release of Highly Efficacious
mRNA Therapeutics & Vaccines for Patients
The 4th mRNA Analytical Development & Quality Control Summit will return in 2025 to reunite the industry, to seek and discuss new guidelines and identify a path forward with tangible best practices to ensure reliable analytical methods are guiding mRNA production, purification and formulation optimization for approval of high quality, compliant mRNA drugs for patients in need.
Designed for Analytical Development, Quality Control, CMC and Regulatory Affairs specialists, the meeting will return with 3 days jam packed with technical sessions, and brand new case studies and discussion opportunities.
In 2024, 100+ experts and enthusiasts from leading biopharma and academia joined to glean insights into future analytical methods to safeguard their regulatory submissions.
Jianmei Kochling
Senior Director, Analytical Development CMC, MRNA Center Of Excellence, Vaccine Research & Development
Sanofi
- Challenges faced in mRNA analysis, such as purity, stability, contamination, and yield to improve quality and efficacy with input from Moderna, Elastrin Therapeutics and Innovac Therapeutics
- Developing best-in-class characterization methods and potency assays with the potential for speeding up analytical methods and ensuring the safety, efficacy and quality of your mRNA therapeutics with insights from Sanofi, Beam Therapeutics and Tessera Therapeutics
- Investigating different strategies to control the difference in formulation and heterogeneity of your nanoparticles once administered in the body with input from Regeneron, SalioGen Therapeutics and Johannes Gutenberg-Universität
- Standardizing your mRNA and LNP analytical techniques in line with expected critical quality attributes to allow efficient and rapid approvals with insights from Genentech, GSK and Replicate Bioscience
