ANALYTICAL/QUALITY ARTICLES
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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.
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Proteomics Tools: A Resurrection
For decades, the evolution of proteomics has lagged. Now, a resurrection is underway. New tools are dismantling limitations, signifying a maturation of systems biology.
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The "Middle Ground" Advantage: Why Alnylam Is Betting Big On Chemoenzymatic Ligation
Though conversations are picking up around this hybrid approach, we aren’t exactly known as an industry that embraces risk no-holds barred. While there are a handful of manufacturers and CDMOs who are embracing the hybrid model today, there are many more that are likely to hold out for the next-next gen approach: Fully enzymatic oligo production. However, as Alynlam’s CTO and Chief Quality Officer Tim Maines argued, embarking into the “middle ground” of enzymatic ligation is essential for garnering the step-by-step learnings needed to help us unlock even bigger manufacturing wins in the future.
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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.
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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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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.
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A&M STABTEST Expands Service Offerings In Protein And Oligonucleotide Analysis With LC-MS System
CRO upgrades systems to provide regulatory compliance for large-molecule protein analysis, expanding their oligonucleotides capabilities.
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Automated NGS Solutions Advance Rare Disease Research
See how a unified NGS workflow is helping a major pediatric genetics lab boost efficiency, manage growing sample volumes, and accelerate insights into rare diseases through streamlined automation.
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Five Essentials For Accurate Oligonucleotide Chemistry
Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.
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Structural Characterization Of RNA And Detection Of RNA-Ligand Binding
Delve into the intricacies of riboswitch behavior and ligand interactions and gain valuable insights into gene regulation and potential therapeutic targets.
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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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Lentiviral Vector Characterization For Cell And Gene Therapy Manufacturing
This study focuses on characterizing recombinant LVVs used in gene-modified cell therapies, utilizing two real-time PCR assays adapted to the QuantStudio™ Absolute Q™ Digital PCR System.