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.

Advancing RNA-LNP Therapeutics As An Alternative To Viral Vectors

RNA-LNP therapeutics offer a flexible, transient alternative to traditional viral vectors for genetic medicine. Learn about the advantages of LNPs in safety, scalability, and payload versatility.

How A Drug's Molecule Type Affects Several Bioanalysis Parameters

Discover why bioanalytics are crucial to selecting promising drug candidates during development and to characterizing the pharmacokinetic and pharmacodynamic profile of the drug in early clinical trials.

Nanomedicine Modalities Find Path To Clinic Through Analytics

Lipid nanoparticles have revolutionized drug delivery, ushering in a new era of nanomedicine. Discover how advanced analytical tools are accelerating next-generation LNP therapeutics.

dsRNA: Why Polymerase Choice Matters

Polymerase selection during IVT shapes dsRNA levels, processing costs, and product quality. See how enzyme engineering reduces abortive transcripts and improves purity profiles for complex mRNA manufacturing applications.

Best Practices For Analysis Of IVT mRNA

Discover how an automated capillary electrophoresis system provides robust and precise integrity, concentration, and size analysis for IVT mRNA.

Suitability Testing For IVT mRNA Analysis

Automated capillary electrophoresis provides robust, precise analysis of IVT mRNA integrity, concentration, and size, demonstrating excellent method precision.

The Absolute Essentials Of Manufacturability

Learn why integrating Quality by Design (QbD) and Process Analytical Technology (PAT) early on is essential for developing a robust, controlled, and financially viable process.