On April 14 and 15, 2026, the Alliance for mRNA Medicines (AMM) and U.S. Pharmacopeia (USP) convened leading scientists, industry innovators, and regulatory experts for a workshop focused on advancing analytical solutions that support the manufacturing, characterization, and quality control of mRNA therapeutics.
Strengthening the mRNA Ecosystem
The event kicked off with the guiding sentiment – RNA therapies are some of the most cutting-edge medicines in the world, and we’ve only just begun to see what these can do – and presenters underscored the importance of analytical rigor in supporting the next generation of mRNA medicines.
Speakers from industry, academia, and standards‑setting organizations presented emerging approaches in mRNA characterization, including advances in liquid chromatography, sequencing‑based analytics, dsRNA detection, potency assays, and mass photometry. Sessions also explored standards approaches and strategies for controlling DNA starting materials, assessing capping efficiency, and correlating physical and functional attributes to critical quality parameters.
Day 2 focused on analytical platform methods, featuring insights into lipid nanoparticle (LNP) product development, single‑particle characterization for LNP therapeutics, RNA distribution within LNPs and their impact on gene-editing, and the complexities of targeted lipid nanoparticles (tLNPs). Sessions also explored high‑throughput assays for capping efficiency and mRNA manufacturing processes.
A closing panel assessed what is needed most to advance the analysis of mRNA in light of emerging technologies, what is needed to overcome hurdles in mRNA characterization, and how the scientific community can come together to streamline agreed upon parameters to adapt new analytical methodologies.
Across the two-days, the workshop reinforced that robust analytical solutions are foundational to unlocking the full therapeutic potential of mRNA. The analytical tools being developed today will shape the safety, reliability, and scalability of mRNA medicines and drive this modality forward.
Speakers
The program featured a broad lineup of experts:
- Adam Crowe, Cytiva
- Albert Kamanzi, ScopeSys Inc.
- Chiara Bruckmann, Thermo Fisher Scientific
- Jan Falcke, BioNTech
- Jean de Seze, Dillico
- Jonathan Mitchell, Promega Corporation
- Kala Dasuri, Sanofi
- Khaled Yamout, Yamout Chem Consulting
- Mark Lowenthal, National Institute of Standards and Technology (NIST)
- Martin Gilar, Waters Corporation
- Matt Ranaghan, Refeyn
- Mohamad Toutounji, Molgenium
- Sarita Kattel, USP Global Biologics
- Shigeki Miyake‑Stoner, Replicate Bioscience
- Sixuan Li, Johns Hopkins University
- Sonia Taktak, Pfizer
- Wayne Doyle, Eclipsebio