Order, Chaos, And The mRNA Black Box: Takeaways From The USP/AMM Forum

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.

From Supporting Component to Strategic Driver: The Evolving Role of gRNA in CRISPR Therapeutics

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.

The RNA Ties That Bind: 3 Takeaways From The OPT Congress

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.

Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign

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.

MicroRNA Therapeutics In Metabolic Liver Disease: Context-Driven Drug Discovery

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

Inside Alnylam's Playbook For High Volume siRNA Production

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.

Analytics And Bioassays Can Safely Fast-Track mRNA-LNP Drug Development

One main mRNA technology challenge is the formulation of delivery systems like lipid nanoparticles (LNPs). Learn about evading impurities in lipids, the future of mRNA-based genomic medicines, and more.

Targeted LC-MS/MS Detection Of Lipid Impurities In Lipid Nanoparticles

Learn about an HPLC-MS/MS method for detecting lipid impurities in lipid nanoparticles (LNPs) and why it is critical for quality control of LNP-based drug delivery systems.

Lessons From Benchmarking Of dsRNA Across Polymerase Systems

Not all low-dsRNA claims hold up under direct comparison. A 15-enzyme IVT study identifies the few systems that actually deliver across yield, integrity, and dsRNA simultaneously.

Sequencing Of Synthetic Oligonucleotides And Their Impurities

We demonstrate an automated, compliance-ready liquid chromatography-mass spectrometry (LC-MS) workflow for sequence confirmation of oligonucleotides and their impurities.

High-Sensitivity IVT mRNA Analysis

Quality analysis of in vitro transcribed (IVT) has become an essential part of biotherapeutic workflows. Discover a high-sensitivity kit made for analyzing IVT mRNA quality to advance your research.

How To Navigate Through The Jungle Of Columns?

Whether prioritizing mass spectrometry compatibility or loading capacity, understanding the specific trade-offs between IP-RP, AEX, and SEC methodologies is essential for successful characterization.

5 Key Questions On How To Accelerate mRNA Development

Stakeholders are working to solve key mRNA manufacturing challenges, including how raw materials impact product quality and how to address scale up. Though existing analytical and manufacturing technologies may fall short for mRNA, investment in innovative techniques will help meet increasing demand for personalized therapeutics.