MANUFACTURING ARTICLES
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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.
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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.
MANUFACTURING VIDEOS
During this first segment of Cell & Gene Live, Major Trends in Next-Gen RNA Engineering, hosted by Cell & Gene’s Chief Editor, Erin Harris, Nathaniel Wang, CEO and Co-Founder, Replicate Bioscience and Sam Deutch, EVP of Research and Early Development at Nutcracker Therapeutics discuss the two major trends developing in the next generation RNA space. They cover how to more accurately target tissues to reduce off-target effects or to cross a therapeutic threshold for protein expression. In addition, they discussed how to improve the amount, quality, and longevity of expressed protein to expand the use cases for RNA.
In this video, Russell Johnson, VP Formulation Research for RVAC Medicines, and Aalok Shah, Director of Formulation & Drug Delivery for Strand Therapeutics, outline several examples of foundational research that could provide insights into how we attain more specific cellular uptake of LNPs.
Discover how our advanced capabilities in Hopkinton, MA, are overcoming the challenges of large-scale RNA therapeutic manufacturing, enabling the efficient production of complex srRNA and mRNA therapies.
Is enzymatic ligation a futuristic dream or a current commercial reality? In this segment, industry experts Claire MacCleod and Jill Caswell explore how the sector has moved past the proof-of-concept stage into early commercialization and what this looks like/means for early adopters today.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1648451263 Scientist Holding Tray Of Medical Samples In Lab]( "Continuous Nanoparticle Manufacturing For Gene Editing Delivery")
Messenger RNA-LNPs are a promising strategy for delivering gene-editing components. Learn how a continuous manufacturing platform can address the scalability and reproducibility challenges of this process.
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![GettyImages-1327109659-scientist-lab-smile-happy]( "Tangential Flow Filtration System Coupling To Enhance Solution Offerings")
Discover a simple, easy, and versatile method for capsule and depth filtration of small volumes that moves research from cell harvest to purification as quickly and efficiently as possible.
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![Gene Therapy iStock-1291142726]( "Key Challenges for CRISPR In Clinical Development")
Learn how to approach CRISPR cell and gene therapy development challenges, such as regulatory hurdles, ensuring consistency, finding qualified and experienced staff, and obtaining GMP-Grade reagents.
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This study demonstrates an optimized cooling protocol for cryopreserving large-volume cryovials in a controlled-rate freezer, avoiding the need for liquid nitrogen.
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![GettyImages-2148124393 DNA]( "A Risk-Based Approach To Plasmid DNA And mRNA Process Development")
Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.
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![cell-therapy-GettyImages-1494029118]( "Frozen Materials For Early Stability")
Fresh starting materials add variability and fragility, while frozen inputs create predictable, scalable workflows that improve consistency, lower risk, and support smoother early‑phase development.
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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.
