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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Exploring Osmolality As A CQA Within RNA Therapeutics
Discover how osmolality can be applied throughout the bioprocessing workflow for RNA, and recognize the importance of this sensitive measurement, from formulation optimization to cryopreservation techniques.
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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.
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Future-Proofing mRNA Drug Manufacturing: The Value of Continuous Improvement
With so many uncertainties permeating the mRNA market, this largely preclinical industry is still seeking answers on how to reach successful therapeutic development. Identifying optimizations, both sequence-dependent and otherwise, to enhance the manufacturing process is crucial for advancing mRNA product development, which holds vast potential to address a wide range of indications.
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NGS Analysis Of Hereditary Cancer Predispositions
Examine how a molecular genetics team improves NGS efficiency and library quality through streamlined automation, intuitive QC tools, and reliable workflows, boosting reproducibility.
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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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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.
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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.