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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In vitro transcription (IVT) allows a researcher to tailor synthesis and introduce modifications to produce a transcript. Learn about IVT along with process challenges and strategies.
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Learn about the isolation and purification benefits of a resin that is particularly useful in the manufacturing in vitro transcribed mRNA.
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Explore how Difco™ TC Yeastolate ultra-filtered (TCY UF) enabled over 100% improvement in titer for CHO cell culture through feed optimization and bioreactor scalability in a real-world application.
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Cell therapy’s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.
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mRNA poly(A) tail analysis depends on targeted digestion, clean LC/MS conditions, and reliable deconvolution. See how RNase 4 digestion and optimized ion-pairing methods support reproducible results.
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Encapsulated mRNA–LNP creation begins with synthesizing the DNA template. Explore insights on DNA template synthesis, the challenges and strategies of generating a DNA template using PCR, and more.
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Find out more about the key steps for successful mRNA vaccine production, which encompasses mRNA manufacturing, and ways that you can save valuable time from the start of manufacturing.