ANALYTICAL/QUALITY ARTICLES
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![genetic engineering and gene manipulation, CRISPR technology, genome editing, molecular biotechnology, genetic science research, gene therapy-GettyImages-2196575232]( "From Supporting Component to Strategic Driver: The Evolving Role of gRNA in CRISPR Therapeutics")
From Supporting Component to Strategic Driver: The Evolving Role of gRNA in CRISPR TherapeuticsGuide 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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![RNA, ribonucleic acid-GettyImages-2195556279]( "5 Key Questions On How To Accelerate mRNA Development")
5 Key Questions On How To Accelerate mRNA DevelopmentStakeholders 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.
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![Business support, teamwork-GettyImages-2267605245]( "The RNA Ties That Bind: 3 Takeaways From The OPT Congress")
The RNA Ties That Bind: 3 Takeaways From The OPT CongressHere, 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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![Test Tubes-GettyImages-139700261]( "Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign")
Rethinking ATMP Assurance When Sterility Timelines, Reality MisalignThe 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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![Liver Pop Art-GettyImages-531038489]( "MicroRNA Therapeutics In Metabolic Liver Disease: Context-Driven Drug Discovery")
MicroRNA Therapeutics In Metabolic Liver Disease: Context-Driven Drug DiscoveryRealizing the therapeutic potential of miRNAs in liver disease requires confronting a problem the field has not fully reckoned with.
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![Game Strategy-GettyImages-169983235]( "Inside Alnylam's Playbook For High Volume siRNA Production")
Inside Alnylam's Playbook For High Volume siRNA ProductionAs 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.
ANALYTICAL/QUALITY VIDEOS
In this segment, Replicate Biosciences’ Andy Geall, Qian Ruan, & Alex Aust identify the most promising technological and raw material innovations that are influencing the drug substance and drug product production processes at CDMOs.
Learn how a new biophysical characterization strategy can enhance RNA therapeutic candidate screening and formulation development through a deeper understanding of RNA structure under native conditions.
As CRISPR technology evolves beyond the original Cas9, gRNAs are transitioning from simple targeting tools into highly engineered, complex molecules. In this Advancing RNA Live segment, speakers April Sena, Max De Long, and Venkat Krishnamurthy discuss how the rise of diverse nucleases — including prime editors — is impacting gRNA synthesis and purity.
In this Advancing RNA Live clip, CMC consultant Sujit Jain unpacks the levels of maturity he’s observed in process and analytical development, as well as supply chain. While vaccines and liver-targeting therapeutics boast what we can call a reproducible platform today, targeted LNP therapies introduce a handful of scale-up sensitivities and characterization hurdles.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![molecule-1184397025]( "Understanding The Intricacies Of qMSI")
Understanding The Intricacies Of qMSIExplore 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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![GettyImages-2214027408 lab_research_microscope]( "IR Spectral Signatures Of GC, AU, And GU Base Pairing In H2O-Based Buffer By MMS")
IR Spectral Signatures Of GC, AU, And GU Base Pairing In H2O-Based Buffer By MMSExplore a label-free approach to characterize RNA structure with high sensitivity. See how specific base pair types are resolved, providing a clearer picture of RNA folding.
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![GettyImages-1295693748-mRNA-strand]( "Analyzing Poly(A) Tails Of In Vitro Transcribed RNA")
Analyzing Poly(A) Tails Of In Vitro Transcribed RNAFind 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.
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![iStock-1208824917-molecule-structure]( "Metabolite ID And Relative Quantification Of Oligonucleotides In Plasma")
Metabolite ID And Relative Quantification Of Oligonucleotides In PlasmaThis technical note describes the identification, relative quantification, and structural confirmation of the chain-shortened metabolites of a phosphorothioated oligonucleotide.
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![Thermo Fisher - Peptones]( "The Value Of Peptones For Enhancing Biopharmaceutical Productivity")
The Value Of Peptones For Enhancing Biopharmaceutical ProductivityPeptones, versatile media additives derived from various sources, offer numerous benefits for biopharmaceutical production.
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![mRNA GettyImages-1428646288]( "Establishing Analytical Methods For mRNA-Based Therapies")
Establishing Analytical Methods For mRNA-Based TherapiesHere, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
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![Vial drug development.jpg]( "Top 8 Benefits Of Mass Spectrometry Imaging Early In Drug Development")
Top 8 Benefits Of Mass Spectrometry Imaging Early In Drug DevelopmentHere we explore the top 8 benefits of using mass spectrometry imaging in the oncology drug discovery and early development stages.
