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.

Preventive Control Of Sequencing Through The Insert

Understanding library size distributions helps prevent sequencing through the insert, reducing adapter read‑through. Explore how smear analysis guides optimal read‑length selection to avoid noise.

Ultra-Sensitive Assay For Anti-Sense Oligonucleotide Quantification

Learn about a new level in sensitivity for challenging analytes in matrix that opens doors for accurate bioanalysis and metabolism studies with specificity not achievable with orthogonal methods.

Accelerating IND-Enabling Studies With Automated Bioanalysis Workflows

Reimagined as automation-first, bioanalysis shifts from being an Investigational New Drug (IND) bottleneck to a catalyst for innovation—helping companies move therapies forward with greater confidence.

Comparison Of Constant- And PulsedField Electrophoresis

Accurate sizing of large DNA fragments is crucial in long‑read sequencing. Examine how different electrophoresis methods perform with 10–20 kb smears and how to choose the most reliable approach.

Engineered Enzymes Powering The Future Of mRNA Therapeutics

Optimizing RNA polymerase selection significantly improves mRNA yield and purity while reducing dsRNA. Discover how advanced enzyme engineering enhances therapeutic manufacturing efficiency and safety.

mRNA Product Purification Process Strategies

Impurities from IVT can induce undesired immune responses and negatively impact translation efficiency. Explore the pros and cons of each option for mRNA purification.

Exploring The Spatial Distribution Of mRNA-Lipid Nanoparticles Using MALDI MSI

Learn how leveraging high-resolution MALDI-MSI can advance the development of lipid nanoparticle-based therapies, uncovering spatial biodistribution, pharmacokinetics, and organ-specific variability.