RNA Manufacturing Articles

1. Is mRNA Manufacturing Overbuilt? 9/15/2026

   mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.

2. What Oligo Manufacturing Risks Are We Underestimating? 9/8/2026

   Earlier this year, I attended the OPT Congress, where I had the great fortune of meeting consultant Marc Lemaitre. I recently sat down with Lemaitre for a follow-up interview to gauge some of the evolutions he’s been watching within the CMC landscape for oligo development. Here, he digs into the shifts in quality he’s noted, pointing out some of the potential pitfalls we may encounter in our manufacturing that could stand to impact the overall quality of our oligos. 

3. RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating Innovation 9/3/2026

   From a tech perspective, the manufacturing objective is shifting toward integrated process optimization. Automated reaction control, multivariate analytics, and more can connect molecular quality with operational performance. 

4. What Baby KJ Taught Us About mRNA COGS 8/25/2026

   Here, in part 2 of this three-part series, I share a few details that came to light about the COGS behind Baby KJ’s therapy production. Obviously, we know why it’s important to keep these figures in mind as we move forward; but I particularly liked Strauss’ reminder that it’s our job to “think systematically about how we’re going to create a safety net of sustainable, accessible product that can be widely distributed at an affordable cost.”

5. Analytical Platforms: The Foundation Of The Next Generation Of RNA Therapeutics 8/11/2026

   RNA therapeutics are entering a new era where analytical platforms drive scalability, regulatory confidence, manufacturing flexibility, and the development of increasingly complex products.

6. A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA Products 8/10/2026

   NIST research introduces a gentle SEC method that separates dsRNA impurities from IVT mRNA by tweaking buffer pH, achieving 81.8% target recovery without transcript damage.

7. The Preclinical Gauntlet: Securing Capital And Designing Regulatory Pathways For Ultra-Rare ASO Drugs (Pt. 2) 8/7/2026

   SynaptixBio CEO Dan Williams explains why funding, regulatory strategy, toxicology, and disciplined execution — not just science — determine success in advancing ultra-rare ASO therapies.

8. Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2) 8/6/2026

   European RNA biotech leaders can accelerate U.S. success by aligning fundraising, partnerships, manufacturing, hiring, and regulatory strategy from day one.

9. The Delivery Challenge For In Vivo Cell Engineering 7/30/2026

   As RNA therapies expand beyond the liver, delivery—not payload design—has become the defining challenge for precise, scalable in vivo cell engineering.

10. Building An ASO For TUBB4A-Related Leukodystrophy (Pt. 1) 7/28/2026

    SynaptixBio CEO Dan Williams explains how the company selected an ASO for TUBB4A leukodystrophy by balancing potency, safety, and translational rigor to advance a rare disease therapy.