MANUFACTURING ARTICLES
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![economy law of supply and demand-GettyImages-1263079550]( "Is mRNA Manufacturing Overbuilt?")
Is mRNA Manufacturing Overbuilt?mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.
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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.
MANUFACTURING VIDEOS
Explore the future of nucleic acid and nanoparticle-based therapeutics, including mRNA, CRISPR, and gene editing, as experts discuss innovative solutions for complex health challenges.
Discover a compact, fully automated oligonucleotide synthesizer for robust, scalable process development. Learn how it can help establish a robust and reproducible oligo synthesis process.
Explore an overview of the development and scale-up activities needed to develop high quality lipid nanoparticles and progress this saRNA vaccine to the clinic.
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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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![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-1090255620-lab-research-microscope-computer]( "When Is A New Biologic Ready For GMP Production?")
While there are differences by modality in DNA, RNA, and protein, find general recommendations on questions to prepare for and steps to consider when preparing to move to clinic.
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![GettyImages-1371707479-lab-mask-team-partnership]( "mRNA/saRNA Manufacturing RNA Program Development & Support")
Venkata Indurthi, Ph.D., shares his knowledge and experience with manufacturing RNA, including key upstream and downstream considerations that go into process development for RNA drug substance manufacturing.
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![Scientist syringe vaccine GettyImages-1351831059]( "Overcome The Supply Chain Complexities Of Vaccine Development")
Explore the industry impact of rapidly evolving vaccinology, the power of next-gen science and technology, and how finding the right supply chain partner has never been more essential.
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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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![GettyImages-970394878-genetic-engineering-gene-editing-dna]( "Genome Editing Using mRNA-Lipid Nanoparticles For CAR T Cell Therapy")
Gene delivery platforms must support a diversity of genetic engineering strategies for genomic medicine development. Learn how lipid nanoparticles can accelerate development from discovery to scale-up.
