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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Gene Therapy And Oligonucleotide Compendium
Technical summaries and detailed protocols for purity testing, sizing, sequencing and expression analysis of oligonucleotide-based active agents as well as protein and lipid-based delivery systems.
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Suitability Testing For IVT mRNA Analysis
Automated capillary electrophoresis provides robust, precise analysis of IVT mRNA integrity, concentration, and size, demonstrating excellent method precision.
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Ultra-Sensitive Assay For Anti-Sense Oligonucleotide Quantification
Learn about a new level in sensitivity for challenging analytes in matrix that opens doors for accurate bioanalysis and metabolism studies with specificity not achievable with orthogonal methods.
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Understanding The Intricacies Of qMSI
Explore quantitative mass spectrometry imaging (QMSI) and leading spatial bioanalysis and biology services that offers one-on-one support throughout your drug development process.
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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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Large Scale Purification Of Oligonucleotides With IEX
As oligonucleotide-based drugs gain momentum in therapeutic development, refining their manufacturing processes through solutions like ion exchange chromatography (IEX) becomes crucial.
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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.