ANALYTICAL/QUALITY ARTICLES
-
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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
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.
-
Optimizing mRNA For Success: A Guide To Enhanced Stability, Delivery, And Efficacy
RNA offers exciting potential for vaccines, gene therapies, and personalized medicine, but challenges related to stability, delivery, and manufacturing persist.
-
Detection Of Adapter Dimers In NGS Libraries
Accurately identifying low‑level adapter dimers is key. Compare electrophoresis methods to show how different kits detect and resolve small fragments, helping researchers choose the best QC approach.
-
Analyzing Poly(A) Tails Of In Vitro Transcribed RNA
Find out how to achieve reliable IVT mRNA quality. Learn the best practices for precise analysis, including proper sample prep and system optimization for high-resolution results.
-
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.
-
Assigning IR Absorption Bands For RNA Building Blocks Using Microfluidic Modulation Spectroscopy
Explore the power of MMS in identifying RNA base signatures. This study analyzes vibrational modes of A, G, C, and U, revealing insights into electronic environments and molecular interactions.
-
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.