MANUFACTURING ARTICLES
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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.
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![MacKay suspension bridge-GettyImages-2281791194]( "Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)")
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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![GettyImages-1494348289_lab microscope]( "The Delivery Challenge For In Vivo Cell Engineering")
The Delivery Challenge For In Vivo Cell EngineeringAs RNA therapies expand beyond the liver, delivery—not payload design—has become the defining challenge for precise, scalable in vivo cell engineering.
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![GettyImages-480155972_Leukodystrophy]( "Building An ASO For TUBB4A-Related Leukodystrophy (Pt. 1)")
Building An ASO For TUBB4A-Related Leukodystrophy (Pt. 1)SynaptixBio CEO Dan Williams explains how the company selected an ASO for TUBB4A leukodystrophy by balancing potency, safety, and translational rigor to advance a rare disease therapy.
MANUFACTURING VIDEOS
Join our webinar on scaling the CTS LV-MAX System in bioreactors, covering transfection scalability, Thermo S.U.B. advantages, and DynaSpin’s efficient gene therapy integration.
In this Bioprocess Online Live panel discussion, experts share the most important factors to consider when assessing the manufacturability of novel linear mRNA candidates in order to bring forward the most successful lead candidates.
Three LNP experts from Sanofi, Hopewell Therapeutics, and BioNTech collectively discuss how far we’ve come in understanding the structure of our LNPs while also shedding light on the variables that have the greatest potential of causing shifts in our products’ structure/function.
In this video, Russell Johnson, VP Formulation Research for RVAC Medicines, and Aalok Shah, Director of Formulation & Drug Delivery, Strand Therapeutics, discuss what industry challenges should be top of mind for experts as it relates to the regulatory paradigm, toxicity/safety, and in vivo modeling.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![iStock-1051617224-automation]( "Accelerate GMP Certification With Annex 1-Compliant Aseptic Automation")
Rapid GMP certification is possible with Annex 1-aligned aseptic workflows that reduce contamination risks. Learn how advanced automation and isolator technologies help CDMOs meet regulatory demands.
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![GettyImages-525440891-lab-research-development]( "Avoiding The Pitfalls Of LNPs And Complex Formulations")
Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.
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![GettyImages-1470034194-magnifying-glass-charts-calculator]( "Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators")
Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.
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![DNA]( "Can mRNA Disrupt The Biopharma Industry?")
mRNA has the potential to revolutionize the field of vaccine development. However, it is critical we understand any factors that could impact its successful entry into today’s market.
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![Precision NanoSystems Feature]( "Understanding The Microfluidic Platforms For Scaling Nanoparticle Production")
Learn about the benefits of microfluidics for nanoparticle production over traditional methods as well as scaling nanoparticle production for clinical or industrial use.
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![iStock-1293772874-lab-plasmid-gene therapy-DNA]( "Novel Lipid Nanoparticle Delivery Reagent And Manufacturing Workflow")
We aim to highlight that commercially available LNP reagent mix, GenVoy-ILM, is an accessible and easy-to-use LNP formulation that allows for rapid preclinical development of RNA vaccines.
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![PCR Plate GettyImages-867159726]( "Meeting Regulatory Requirements With Confidence")
An outbreak of mycoplasma can halt a biopharmaceutical facility's production for months. Explore the impact of mycoplasma contamination and the most accurate and sensitive way to detect it.
