RNA Analytical/Quality Articles

  1. MicroRNA Therapeutics In Metabolic Liver Disease: Context-Driven Drug Discovery 3/12/2026

    Realizing the therapeutic potential of miRNAs in liver disease requires confronting a problem the field has not fully reckoned with.

  2. Inside Alnylam's Playbook For High Volume siRNA Production 3/10/2026

    As one of the first companies to establish a chemoenzymatic ligation platform, Alnylam's Maines and Nechev are in the perfect position to espouse wisdom on the practical aspects and remaining challenges of implementing enzymatic ligation at a large scale. Here in this installment, Maines and Nechev outline what they’ve learned thus far about the science of enzymatic ligation, while also paying credence to the unknowns and existing barriers that, as a frontrunner, Alnylam will inevitably (but willingly) be tasked with facing in the future.

  3. Proteomics Tools: A Resurrection 3/4/2026

    For decades, the evolution of proteomics has lagged. Now, a resurrection is underway. New tools are dismantling limitations, signifying a maturation of systems biology.

  4. The "Middle Ground" Advantage: Why Alnylam Is Betting Big On Chemoenzymatic Ligation 3/3/2026

    Though conversations are picking up around this hybrid approach, we aren’t exactly known as an industry that embraces risk no-holds barred. While there are a handful of manufacturers and CDMOs who are embracing the hybrid model today, there are many more that are likely to hold out for the next-next gen approach: Fully enzymatic oligo production. However, as Alynlam’s CTO and Chief Quality Officer Tim Maines argued, embarking into the “middle ground” of enzymatic ligation is essential for garnering the step-by-step learnings needed to help us unlock even bigger manufacturing wins in the future. 

  5. The Monster Under The Bed: Defining Potency in the mRNA Space 2/13/2026

    During the CASSS mRNA Symposium last spring, a seemingly simple, straightforward question was raised: How are we defining and measuring our product’s potency? But as we already know, this is far from a straightforward question — and, dear reader, based on the resulting discussion amongst regulators and panel members, it became clear we have a lot of different definitions on what potency even is in the mRNA space.

  6. 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.

  7. 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.

  8. 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.

  9. 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?”  

  10. 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.