RNA Analytical/Quality Articles

1. 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.

2. Forum Notebook: Quick Takes From USP’s mRNA Virtual Summit 5/1/2024

   The United States Pharmacopeia held a forum in February to exchange ideas about analytical methodologies and release testing. Here's a recap of the event.

3. Assessing pDNA Purity For Cell & Gene Therapies 5/1/2024

   Plasmid DNA (pDNA) is used in gene therapies, vaccines, and RNA therapeutics. Along each step of development, we need to evaluate potential impurities.

4. mRNA: The Fourth Pillar Of Pharmaceutical Innovation And Intervention 4/26/2024

   mRNA medicines represent the genesis of a fourth pillar of pharma innovation. While exciting, there are several critical challenges we must solve to strengthen this pillar, including stability and deliverability.

5. 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.

6. “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. 

7. Future-Proofing mRNA Drug Manufacturing: IVT And Supply Chain 2/29/2024

   Regulatory and technical uncertainty surrounding mRNA necessitates predictive and proactive innovation enabling better manufacturability assessments, more robust in vitro transcription techniques, and improved downstream processing.

8. Comparability Considerations For mRNA Product Development 2/28/2024

   Given the mRNA-based products' variability and unique challenges, you may need to modify the standard comparability approach. Let’s discuss strategies for any development stage.

9. ARW’s ATMP Manufacturing Must-Reads (OPERA EDITION!) 2/8/2024

   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.

10. From “Barbieland” To ATW 2024: Evolving Beyond “Stereotypical” Advanced Therapies 1/26/2024

    What I was met with this year at Phacilitate's Advanced Therapies Week was an industry that knows its worth, but which is facing similar issues as Barbie around what its long-term identity can be and how it can transcend beyond being just a promising idea. Here, I’ve come up with a few snippets of “identity-chiseling” wisdom for the ATMP space.