MANUFACTURING ARTICLES
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RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating Innovation
From a tech perspective, the manufacturing objective is shifting toward integrated process optimization. Automated reaction control, multivariate analytics, and more can connect molecular quality with operational performance.
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What Baby KJ Taught Us About mRNA COGS
Here, in part 2 of this three-part series, I share a few details that came to light about the COGS behind Baby KJ’s therapy production. Obviously, we know why it’s important to keep these figures in mind as we move forward; but I particularly liked Strauss’ reminder that it’s our job to “think systematically about how we’re going to create a safety net of sustainable, accessible product that can be widely distributed at an affordable cost.”
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Analytical Platforms: The Foundation Of The Next Generation Of RNA Therapeutics
RNA therapeutics are entering a new era where analytical platforms drive scalability, regulatory confidence, manufacturing flexibility, and the development of increasingly complex products.
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A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA Products
NIST research introduces a gentle SEC method that separates dsRNA impurities from IVT mRNA by tweaking buffer pH, achieving 81.8% target recovery without transcript damage.
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The Preclinical Gauntlet: Securing Capital And Designing Regulatory Pathways For Ultra-Rare ASO Drugs (Pt. 2)
SynaptixBio CEO Dan Williams explains why funding, regulatory strategy, toxicology, and disciplined execution — not just science — determine success in advancing ultra-rare ASO therapies.
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Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)
European RNA biotech leaders can accelerate U.S. success by aligning fundraising, partnerships, manufacturing, hiring, and regulatory strategy from day one.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Define a process for your unique mRNA with this interactive guide to pDNA, mRNA, and LNP. Overcome challenges with solutions that can help you develop a next-generation production strategy.
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Delve into the advancements and transformative impact of mRNA vaccine technology on modern medicine and explore how this technology is revolutionizing healthcare for the future and beyond.
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Discover how anion exchange chromatography delivers high loading capacity and clinical-grade purity while addressing common scale-up challenges like aggregation and equipment longevity.
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We showcased the utility of microfluidics to enable low shear, rapid screening of preclinical candidates and the swift advancement to GMP-enabling studies.
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Discover key strategies to optimize siRNA therapeutics by addressing critical nonclinical and manufacturing challenges for a smoother path to commercialization.
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Explore ongoing work to harness different types of HDR templates in order to build cutting-edge systems with the potential to enable point-of-care cell and gene therapy manufacture.
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See how automated electrophoresis and key integrity metrics strengthen NGS workflows by improving sample assessment, streamlining QC steps, and supporting confident decisions.