RNA Manufacturing Articles

1. Enzymatic Ligation: The Next Chapter In siRNA Manufacturing 7/11/2025

   During my three days at TIDES, I sat through several talks about the industry’s progress toward enzymatic ligation approaches for siRNA manufacturing. In the following article, I’ll share a few of the biggest takeaways I garnered from these different presentations, with a particular focus on the efficiencies the industry hopes such efforts unlock in the long-term. 

2. 7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies 7/3/2025

   The U.K.'s MHRA has followed through on its promise to issue guidances to aid industry in understanding the recent changes to regulations for licensure of medicines employing cell and gene therapy technology.

3. 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.

4. Pictures At An [mRNA]Exhibition: What We Can Learn From Picasso (Pt. 1) 6/20/2025

   In my presentation, I argued that there are several lessons we can learn from Picasso that will also help our own industry mature. In the upcoming weeks, I plan to unpack these lessons, highlighting specific instances in which I see our industry taking these lessons to heart and making progress — starting here with lesson 1: Being Innovative Comes After We Master The Basics

5. Engineering The Next Generation Of Lipid Nanoparticles For Advanced Therapeutics 6/10/2025

   Lipid nanoparticles (LNPs) face significant hurdles in clinical use due to challenges with their stability, manufacturing, and understanding how their complex characteristics impact therapeutic efficacy and safety.

6. First AMT Program OK'd Under New FDA Designation — Here's What To Know 5/21/2025

   The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.

7. The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials 5/12/2025

   Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.

8. A Road Map For PAT Monitoring And Control 5/8/2025

   Process analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.

9. EMA Issues Draft Guideline On Quality Aspects Of mRNA Vaccines 5/6/2025

   The EMA's new draft guideline applies to mRNA vaccines for infectious diseases, providing guidance on manufacturing, characterization, specifications, and more. The deadline for public comments is Sept. 30, 2025.

10. Do We Really Understand Plasmid Quality's Effects On mRNA Production? 5/1/2025

    Two experts examine the current guidelines and specs for plasmid DNA and question whether our understanding is sufficient.