RNA Analytical/Quality Articles

1. Stay "Stereocurious": What The Future Holds For Oligo Quality 6/22/2026

   Overall, there were two areas of discussion at TIDES that demonstrate the amount of growth we have yet to do as a space — particularly in the realms of regulatory development and quality. As I intend to showcase here in part 1 of this muti-part article, this year’s TIDES was a great reflection of the tension(s) that can arise as we realize how much space exists between where we are and where we’re going next. 

2. Order, Chaos, And The mRNA Black Box: Takeaways From The USP/AMM Forum 5/4/2026

   To be clear, this year’s USP/AMM quality forum was just as focused on the intricacies of applying/using the methods. But what was equally if not more present in this year’s discussion was our increasing acknowledgement that our understanding of mRNA and its biological mechanisms remains quite messy.

3. From Supporting Component to Strategic Driver: The Evolving Role of gRNA in CRISPR Therapeutics 4/21/2026

   Guide RNA is evolving from a simple targeting reagent into a complex, engineered molecule shaped by expanding CRISPR modalities, increasing length and modification demands, and tighter integration with manufacturability, analytical control, and regulatory expectations.

4. The RNA Ties That Bind: 3 Takeaways From The OPT Congress 4/1/2026

   Here, I unpack three takeaways I had from the OPT Congress, each of which I’d argue are indicative of the interconnectedness across the genetic medicines field.

5. Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign 3/27/2026

   The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.

6. 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.

7. 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.

8. 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.

9. 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. 

10. 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.