The Monster Under The Bed: Defining Potency in the mRNA Space

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.

Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control

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.

The mRNA Supply Chain Revolution: Materials, Methods, And Momentum

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.

In Vivo's Biggest Threat — Comparison To Old Models

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.

Money In The Bank: Why 2025's Setbacks Were The Foundation RNA Needed

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?”  

Striking The Right Balance: The Critical Discussions Driving The mRNA Industry's Next Chapter

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. 

Quantification Of Large Oligonucleotides Using High Resolution MS/MS

Explore how to achieve sensitive, high-resolution analysis of large oligonucleotides, with the opportunity to perform both qualitative and quantitative analysis in a single run.

Elevating mRNA Manufacturing Toward GMP-Readiness

The mRNA Technology Transfer Program empowers LMICs with scalable vaccine production. Learn about a partnership that drives innovation in mRNA and sets a global blueprint for equitable health access.

IR Spectral Signatures Of GC, AU, And GU Base Pairing In H2O-Based Buffer By MMS

Explore a label-free approach to characterize RNA structure with high sensitivity. See how specific base pair types are resolved, providing a clearer picture of RNA folding.

Metabolite ID And Relative Quantification Of Oligonucleotides In Plasma

This technical note describes the identification, relative quantification, and structural confirmation of the chain-shortened metabolites of a phosphorothioated oligonucleotide.

Selection And Evaluation Of Hybridization Capture Probes For LC/MS Analysis Of Oligonucleotides

To overcome challenges in oligonucleotide LC/MS bioanalysis, consider optimizing probe design by evaluating alternative chemistries like PNA for improved recovery and chromatographic performance.

Oligonucleotides: Where We Are And Where We Would Like To Go 

This presentation provides an overview of oligonucleotide bioanalysis's current status and future directions. We will look into the advantages and disadvantages of various bioanalytical techniques.

Twist Of Two: 2D-LC For Oligos

Discover how coupling orthogonal mechanisms reveals hidden impurities and creates a more robust strategy for characterizing complex oligonucleotide samples.