RNA Supply Chain Articles

1. "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.  

2. FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities 10/25/2023

   The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

3. “To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP Principles 3/11/2024

   In the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself. 

4. Assessing Quality Of mRNA Vaccines: Key Considerations 10/12/2022

   To address the need for standards for mRNA vaccines, the United States Pharmacopeia (USP) has convened vaccine experts to identify important quality attributes and to propose test methods that can be used to assess mRNA vaccine products. This article shares those CQAs and analytical procedure tips.

5. How Can We Move RNA Forward In Our Therapeutics Arsenal? 7/18/2022

   RNA technologies, including mRNA therapeutics, have emerged as a promising drug modality. However, they have unique challenges. BioPhorum has dedicated a team to investigate these challenges and this Q&A shares their practical considerations for how to move this field forward.

6. Defining The RNA Therapeutics Industry In 2023 1/16/2023

   Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.

7. The Expanding Patent Landscape For RNA-Based Therapeutics 11/16/2022

   The COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.

8. ARW's ATMP Manufacturing Must-Reads (2024 NEW YEAR'S RESOLUTIONS EDITION!) 1/12/2024

   Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.

9. Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why 11/19/2024

   The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.

10. 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.