MANUFACTURING ARTICLES
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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.
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The Delivery Challenge For In Vivo Cell Engineering
As RNA therapies expand beyond the liver, delivery—not payload design—has become the defining challenge for precise, scalable in vivo cell engineering.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Breaking down the implementation of continuous manufacturing into the following four steps may provide some much-needed guidance as you prepare your network for the future of biomanufacturing.
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GMP-Source, which is a term we coined, serves the purpose as a highly qualified raw material for a generation of virus, messenger RNA template, and transgenic expression of proteins.
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Automation And Digital Solutions Can Help You Reach Your mRNA Manufacturing And Sustainability Goals
Explore how digital solutions help streamline mRNA manufacturing by reducing costs, improving efficiency, and supporting sustainability by creating paperless processes for emerging therapeutics.
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Learn how precise sizing methods reveal nucleosome patterns in cfDNA and help distinguish true signal from extraction‑related artifacts for more reliable genomic analysis.
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Experts at Sartorius discuss the challenges complex molecules present to drug manufacturers today and the vital role suppliers play in fulfilling talent gaps for their customers.
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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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This study showcases the performance of regenerated cellulose flat sheet membranes with a 100 kDa molecular weight cutoff for UF/DF of RNA molecules by TFF.