RNA Supply Chain Articles

1. 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. 

2. Picasso, Pick-Up Lines, & Personalized Medicine: mRNA's Path Forward 6/27/2025

   Overall, my presentation on what the mRNA industry can learn from the artist Picasso singled out a few specific areas from which I felt our industry could garner greater inspiration and operational prowess. But given how “collaborative” many of these sources of inspiration are, I’ve introduced each of my takeaways with a surprisingly relevant (albeit bad) art-themed pick-up line. After all, if there’s one sector that knows it takes more than one to “tango,” it’s the mRNA industry.

3. Multidisciplinary mRNA: What Can We Learn From Other CGTs? 5/20/2024

   Overall, there are four high-level best practices/mindsets I proposed during a recent presentation that I believe will be crucial for us to bring some talented RNA therapeutic role models to the forefront. But there is one best practice that I think is worth emphasizing more than the others.

4. The RNA Therapeutics Supply Chain: A Platform of Relationships 2/13/2024

   Conversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.

5. What Violin Making Can Teach Us About mRNA Therapeutic Quality 8/8/2022

   Managing the mRNA supply chain and working in mRNA process development may not look anything like the work a luthier does to hew an instrument from an ancient spruce tree. But violin craftmanship actually serves as a fantastic metaphor for the challenging work the mRNA therapeutics space is tackling in sourcing and qualifying raw materials and optimizing the critical IVT reaction.

6. 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.

7. ARW's ATMP Manufacturing Must-Reads (ST. PATRICK'S DAY EDITION!) 3/14/2024

   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 roundup article.

8. From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy 10/9/2025

   In this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact. 

9. Therapeutic Oligonucleotides: Regulations & Quality Standards 5/20/2022

   Oligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders, respiratory disorders, cancer, and diabetic retinopathy. This article recaps a recent USP workshop where participants from regulatory agencies, industry, and academia gathered to discuss best practices and perspectives.

10. mRNA Vaccines: Key Considerations For Development & Manufacturing 4/4/2022

    As we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more.