ANALYTICAL/QUALITY ARTICLES
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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.
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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.
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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.
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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.
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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.
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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
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Boost LNP Drug Potency With Optimized Delivery Formulations
Lipid nanoparticles (LNPs) function as a drug delivery system for nucleic acids. Learn about the biomedical applications of LNPs as well as the anatomy, formulation optimization, and safety of LNPs.
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Why Bioanalysis Needs To Break Free From Manual Bottlenecks
Bioanalysis remains one of the most persistent bottlenecks in drug development, with CROs displaying inefficiencies that are no longer operational nuisances but strategic liabilities.
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The Hitchhiker´s Guide To Creating Oligonucleotides From Start To Finish
Producing high-quality oligonucleotides demands precise execution across multiple stages. Gain a clearer understanding of the complete mid-scale production workflow and necessary quality control measures.
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Potent Immune Response With Vernal's LNP-mRNAs
As mRNA medicine continues to evolve, understand how trusted manufacturing partners will continue to play a pivotal role in translating innovative concepts into clinical reality.
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RNA Biotherapeutics — A New Approach To An Old Problem
Check out a brief history of RNA-based therapy and how Droplet Digital™ PCR supports this field of work.
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The Evolution Of Nucleotide Production
From harsh chemicals to gentle enzymes: Explore the groundbreaking shift in nucleotide synthesis, making drug manufacturing cleaner, greener, and more efficient.
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Effects Of mRNA Capping Technologies
This study compares two important mRNA capping technologies by evaluating the mRNA integrity, percent Cap1 content, dsRNA content, in vivo expression, and innate immune activation in mice.