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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The SARS-CoV-2 virus has changed the course of scientific research around mRNA. Learn about mRNA manufacturing, the structure of a mRNA molecule, RNase-free considerations, and more.
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Learn how to approach CRISPR cell and gene therapy development challenges, such as regulatory hurdles, ensuring consistency, finding qualified and experienced staff, and obtaining GMP-Grade reagents.
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Fresh starting materials add variability and fragility, while frozen inputs create predictable, scalable workflows that improve consistency, lower risk, and support smoother early‑phase development.
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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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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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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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Lipid nanoparticles (LNPs) function as a drug delivery system for nucleic acids. Learn about the biomedical applications of LNPs as well as the anatomy, formulation optimization, and safety of LNPs.