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
Three regulatory experts share the topics on which they hope to see further agency clarification in the near-term to help mRNA products make meaningful progress toward/through the clinic.
mRNA therapeutics are applicable to cancer immunotherapies, infectious diseases, and other indications that require protein replacement therapy or antibodies.
Delve into the crucial role of Scope 3 emissions in the biopharma industry's sustainability journey, and learn more about the challenges and opportunities of managing these types of emissions.
Watch this rundown of a novel method for quantifying L-Citrulline, L-Arginine, and L-Argininosuccinic acid using Mitra tip extraction coupled with LC-MS/MS for enhanced accuracy and reproducibility.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Treatment with Nanoparticles Genetic therapy GettyImages-805434264]( "Process Development Considerations For RNA-LNP Therapeutics")
Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).
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![Scientist lab discussion meeting GettyImages-1140779742]( "Single Nucleus Dispensing")
Learn how a single cell dispenser was used to isolate single DNA-labeled nuclei to demonstrate compatibility with snRNA-seq workflows.
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![Oligonucleotide Manufacturing: Take Control Of Your Process]( "Oligonucleotide Manufacturing: Take Control Of Your Process")
What do you need to know before you take your process in-house? A team of experts on nucleic acids therapeutics outlined five key things for you to consider as you make the change.
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![mRNA GettyImages-1356994684]( "mRNA Manufacturing And Formulation")
From fermentation to formulation, mRNA manufacturing requires a toolbox of technologies, services, and expertise. Explore our portfolio of solutions for making, purifying, and formulating mRNA.
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![GettyImages-2190227882-male-scientist-lab]( "LNP-Mediated Cell Transfection In Bioreactors Across Workflows")
Lipid nanoparticles are redefining immune cell engineering. Delve into new data that demonstrates the performance across multiple cell types and bioreactor systems, supporting their potential workflows.
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![GettyImages-1334686671-cold-chain-cryopreservation-logistics]( "Validate Cryopreservation As A Defined Input, Not A Variable")
Treating cryopreservation as a validated, controlled input improves consistency, quality, and patient outcomes by reducing variability across cell therapy manufacturing, storage, and distribution.
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![mRNA GettyImages-1428646288]( "A Guide To mRNA Vaccine Production And Manufacturing Services")
Find out more about the key steps for successful mRNA vaccine production, which encompasses mRNA manufacturing, and ways that you can save valuable time from the start of manufacturing.
