RNA Analytical/Quality Articles

1. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

   In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

2. "Mirror, Mirror…": Reflections On Reducing mRNA Production COGS 4/21/2025

   Here, I outline three overarching words of wisdom I gleaned from Life Edit Therapeutics’ April Sena; Tune Therapeutics’ Tyler Goodwin; and University of Sheffield’s Adi on how the mRNA/RNA industry can better control production costs — particularly as it relates to raw material sourcing and usage.  

3. Plasmid Production: 3 Key Takeaways For mRNA Manufacturing 4/14/2025

   Following my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid. 

4. Britney Spears' Take On Building Platform Analytics for mRNA Therapeutics 4/2/2025

   As many of the presentations throughout the two-day USP quality forum revealed, we’re doing what we must to understand the benefits and the limitations of our methods. Yes, this is painstaking and expensive work. But understanding our methods is also one of the critical steps toward a future in which we can rely upon platform analytical procedures and — channeling our inner Britney Spears — say “[Ooo], I did it again!” to the regulatory agencies for each of the subsequent molecules in our pipelines.  

5. Is The mRNA Payload The Real MVP of Targeted Delivery? 3/24/2025

   As one delightfully colorful quote from a panel discussion at the AMM Ascent meeting last fall reminds us, there’s a lot more to be explored, discussed, and understood as it relates to the mRNA cargo’s role in targeted delivery. 

6. The mRNA Industry's Three Wishes: Can CDMOs Play The "Genie?" 3/5/2025

   During the panel discussion last November, three CDMO execs shared the biggest scientific, regulatory, and technological complexities barring a “magical” solution to each biotech’s wishes. However, as each of the AMM panelists pointed out, there are short- and long-term technological innovations in the works that will be essential in advancing the manufacturing infrastructure for mRNA therapeutics in all their shapes, forms, and scales. 

7. Understanding The New U.K. MHRA 'Draft Guideline On Individualised mRNA Cancer Immunotherapies' 3/5/2025

   The U.K.'s MHRA has released a new draft guideline outlining best practices for drug product design, CMC, and manufacturing of mRNA cancer immunotherapies using LNP delivery systems. The public comment period ends March 31.

8. 10 Ways To Speed Up CMC In Early-Stage Drug Product Development 2/21/2025

   The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.

9. What Do We (Really) Know About DNA Quality For In Vitro Transcription? 2/19/2025

   Gene therapies and nucleic acid medicines are dependent upon a starting DNA template that defines the protein or antigen. The sequence of this template DNA being correct is critical.

10. Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future Directions 2/13/2025

    Overall, I felt that the following initiatives/talking points were demonstrative of the types of creativity and symbiosis that we will need much more of in the near and long-term to foster a healthy and fruitful RNA ecosystem.