MANUFACTURING ARTICLES
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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.
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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.
MANUFACTURING VIDEOS
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.
Enjoy the flexibility of user-definable parameters, allowing you to tailor each step of your process, including concentration via continuous flow, washing, resuspension, and final formulation.
Digitize bioprocess workflows to achieve consistent, paper-free execution that deploys up to 66% quicker than traditional MES with a cloud-based, no-code platform built for single-use bioprocessing.
In this Bioprocess Online Live panel discussion, we talk about where the greatest sources of variability are in our downstream processes and how companies should be approaching the question of “how pure is pure enough?"
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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![clinical-trial-manager-shakes-hand-1358280580]( "The Source Of GMP- How Client Demand Drives Innovation")
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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![GettyImages-1356993441 mRNA]( "Automation And Digital Solutions Can Help You Reach Your mRNA Manufacturing And Sustainability Goals")
Automation And Digital Solutions Can Help You Reach Your mRNA Manufacturing And Sustainability GoalsExplore 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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![DNA strands, genetic biotechnology, gene cell-GettyImages-2154784301]( "Separation Of cfDNA With An NGS Kit On Fragment Analyzer Systems")
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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![Bioprocess Pharma Vial GettyImages-1130423724]( "Talent Crossover: Extend Your Workforce Through Supplier Partnership")
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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![GettyImages-1026593952 tablet, data]( "Difco TC Yeastolate Ultra-Filtered (TCY UF) In Scale-Up Optimization")
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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![GettyImages-1409578453-mRNA-LNP-lipid-nanoparticle-RNA therapy]( "TFF Cassettes With 100 kDa Membranes For RNA And LNP Applications")
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.
