RNA Analytical/Quality Articles

  1. Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control 1/30/2026

    Oligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.

  2. The mRNA Supply Chain Revolution: Materials, Methods, And Momentum 1/30/2026

    mRNA innovation now hinges as much on manufacturing materials as on molecular design, with novel inputs shaping performance, cost, and scalability. As these less-mature materials move rapidly into production, strategic material selection and supplier alignment are becoming critical to manufacturing resilience and long-term success.

  3. In Vivo's Biggest Threat — Comparison To Old Models 1/23/2026

    In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.

  4. Money In The Bank: Why 2025's Setbacks Were The Foundation RNA Needed 1/5/2026

    I saw 2025 as a year that was foundational for our efforts to learn more about the biology and function of our products. However, there were two developments in particular that, to me, encapsulated the trials, tribulations, and ultimately the success of an industry that is doing its damnedest to answer one of the biggest questions facing us: “Why RNA?”  

  5. Striking The Right Balance: The Critical Discussions Driving The mRNA Industry's Next Chapter 11/25/2025

    Now, I cannot claim that I or any of the panelists at CASSS have or had access to a real crystal ball that will show us the future. However, what did come through these discussions loud and clear is that the future of our industry must include “balance.” Here, I’ll unpack a few ways the theme of “balance” presented itself — and no doubt will continue to present itself in the future — as well as how the panelists see us achieving this necessary balance. 

  6. The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic Future 8/20/2025

    There were two additional takeaways I had following my conversation with Kuchimanchi, each of which depicts where there still exists quite a bit of dynamism for an industry which can claim an “established” manufacturing paradigm.

  7. Oligos Step Into The Spotlight: A Growing Force In Genetic Medicine 8/18/2025

    Oligonucleotide therapeutics are experiencing a new wave of momentum. As the science evolves and the market opportunity expands, the landscape is poised for continued growth and diversification.

  8. Beyond Solid-Phase Synthesis: The Momentum of Oligonucleotide Manufacturing 8/13/2025

    Overall, there were three main takeaways I gleaned from our conversation that suggest the oligo sector, though more established than its mRNA cousin, is not comfortable with the status quo and is actively trying to grow beyond the limits of its current manufacturing paradigm. Here in part 1, we’ll start with my number one takeaway, which also comes equipped with a bit of history as to how we find ourselves at our current juncture.

  9. Inside Arbor Biotech's In Vivo Gene Therapy Approach 8/6/2025

    Following recent news about first-in-human testing, two executives discuss the science and manufacturing strategy for the company's lead candidate, ABO-101.

  10. 5 Takeaways From The MHRA mRNA Guidance 7/28/2025

    Having read and reread the MHRA's guidance on personalized mRNA cancer immunotherapies, the following five takeaways will function somewhat as a mind-meld, combining a few of my own thoughts/takeaways with those of the MHRA.