MANUFACTURING ARTICLES
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![Justified Risk-GettyImages-2232143649]( "What Oligo Manufacturing Risks Are We Underestimating?")
What Oligo Manufacturing Risks Are We Underestimating?Earlier this year, I attended the OPT Congress, where I had the great fortune of meeting consultant Marc Lemaitre. I recently sat down with Lemaitre for a follow-up interview to gauge some of the evolutions he’s been watching within the CMC landscape for oligo development. Here, he digs into the shifts in quality he’s noted, pointing out some of the potential pitfalls we may encounter in our manufacturing that could stand to impact the overall quality of our oligos.
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![DNA Structure with molecule-GettyImages-2199475157]( "RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating Innovation")
RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating InnovationFrom 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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![money loss, spending, poor financial management-GettyImages-2224880481]( "What Baby KJ Taught Us About mRNA COGS")
What Baby KJ Taught Us About mRNA COGSHere, 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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![intelligent technology interface, robot chat-GettyImages-2279572840]( "Analytical Platforms: The Foundation Of The Next Generation Of RNA Therapeutics")
Analytical Platforms: The Foundation Of The Next Generation Of RNA TherapeuticsRNA 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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![nucleic acid, DNA, RNA, purified protein-GettyImages-1350828873]( "A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA Products")
A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA ProductsNIST 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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![Leukodystrophy Awareness Month-GettyImages-2166836167]( "The Preclinical Gauntlet: Securing Capital And Designing Regulatory Pathways For Ultra-Rare ASO Drugs (Pt. 2)")
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.
MANUFACTURING VIDEOS
In this clip from a recent Advancing RNA LIVE event, panelists address a question about where the best opportunities exist upstream and/or downstream to increase mRNA manufacturing efficiencies.
In this Bioprocess Online Live panel, we discuss the current state of the mRNA supply chain for critical raw materials and manufacturing supplies and where pain points still exist.
TFF Pharmaceuticals’ Kayla Hannon and University of Sheffield’s Dr. Zoltán Kis discuss the cost and capacity implications of therapeutic demand surges in this Surge Manufacturing for Biopharma Resilience segment.
mRNA therapeutics are applicable to cancer immunotherapies, infectious diseases, and other indications that require protein replacement therapy or antibodies.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Developing mRNA Vaccines GettyImages-1307593959]( "Nucleic Acid Therapeutics And Environmental Impact")
Nucleic acid therapeutics offer exciting new avenues of treatment. Learn about the history of nucleic acid therapeutics and the environmental impact of manufacturing mRNA and oligonucleotides.
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![GettyImages-1256323645 lab, biotech]( "Genetic Engineering Medium Aiding The Transfection Of MSCs With siRNA")
A newly developed genetic engineering medium is fueling the development of cell- and extracellular vesicle-based therapies.
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![GettyImages-2189138619 lab]( "5 IVT Design Considerations Before Scale-Up")
As RNA programs advance toward clinical manufacturing, five IVT design questions can help teams identify hidden process risks before scale-up exposes them.
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![GettyImages-1087219020 Scientists wearing protective coveralls working in manufacturing laboratory]( "Insights Into GMP Manufacturing Of RNA-LNP Drug Products")
Explore key considerations for manufacturing RNA-LNP drug products surrounding process and analytical development, automation, environmental monitoring, and strategic collaborations.
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![GettyImages-2009511436 3D illustration of small extracellular vesicles (exosomes)]( "Exosome Isolation By TFF And Size Exclusion Chromatography")
Here, we demonstrate a scalable workflow for the isolation of exosomes that combines tangential flow filtration for the concentration of exosomes followed by gentle size exclusion chromatography.
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![GettyImages-2270210340-lipid-nanoparticle-delivery-system]( "Extrahepatic Delivery Of mRNA-LNP To Spleen")
In vivo CAR-T approaches aim to reprogram T cells directly in the body using targeted lipid nanoparticles. Improved delivery to immune organs highlights new potential for scalable cell therapies.
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![GMP Manufacturing Facility For Viral Vector Production]( "GMP Manufacturing Facility For Viral Vector Production")
A new GMP production facility for viral vectors from nonadherent cell cultures alleviates concerns that there will be a restriction of speed in getting viral vector products from the laboratory to the patient.
