ANALYTICAL/QUALITY ARTICLES
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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.
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The mRNA Supply Chain Revolution: Materials, Methods, And Momentum
mRNA innovation now hinges as much on manufacturing materials as on molecular design, with novel inputs shaping performance, cost, and scalability. As these less-mature materials move rapidly into production, strategic material selection and supplier alignment are becoming critical to manufacturing resilience and long-term success.
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In Vivo's Biggest Threat — Comparison To Old Models
In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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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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mRNA Product Purification Process Strategies
Impurities from IVT can induce undesired immune responses and negatively impact translation efficiency. Explore the pros and cons of each option for mRNA purification.
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Assessing Doggybone DNA For In Vitro Transcription
In this study, we evaluated the performance of two dbDNA IVT templates, each encoding the same mRNA (firefly luciferase or Fluc), by looking at the mRNA purity and in vivo potency of the mRNA IVT’d from each template.
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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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Replicate Bioscience And Cytiva Collaborate To Deliver srRNA-LNP Vaccines
Discover how self-replicating RNA (srRNA) can revolutionize vaccine development with sustained protein expression, lower doses, and fewer side effects to advance next-gen RNA therapeutics.
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Precision In Nanoparticle Processing And Monodispersed Lipid Nanoparticles For Advanced Therapeutics
Precision in nanoparticle processing is key for drug delivery and vaccines. Learn how monodispersed formulations enhance reproducibility and stability for next-generation therapeutics, like RNA-LNPs.