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 features of this benchtop system including the dual pump module, mixer module, collection module, software, and additional features.
LNPs made using Helix Biotech's Nova BT IJM manufacturing system.
We share our experience working with organizations as they adopt solutions for automated data acquisition, aggregation, visualizations, and statistical analysis.
An industry expert shares about sustainable Oligo manufacturing approaches that can save time, cost, and resources – while improving purity, quality, and scalability of these promising therapeutics.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1360244592-frozen-organ]( "Where Innovation Is Moving The Advanced Therapies Supply Chain")
Assimilate how advanced therapy supply chains are evolving toward patient-centric, risk-managed, digitally connected models to support scale, reliability, and regulatory confidence globally today.
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![Molecule mRNA-GettyImages-1428646288]( "Getting IVT Right: Improving Capping Efficiency")
Discover how Codex® HiCap RNA Polymerase can enhance mRNA capping efficiency, reduce costs, and streamline your IVT manufacturing process.
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![Lipid Nanoparticle mRNA Vaccine GettyImages-1418152448]( "Fit-For-Purpose Lipids Can Accelerate, Scale, And Improve RNA-LNP Drugs")
Emerging biotech companies are investing in novel delivery capabilities to address different modalities' needs and extra-hepatic delivery. Explore steps to accelerate commercial nanomedicine delivery.
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![GettyImages-2190246741 lab]( "Phase-Appropriate Approaches To Manufacturing And Testing")
Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.
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![Worker Holding Vaccine Vial GettyImages-1403976499]( "LNP Formulation For mRNA Delivery")
Microfluidic mixing is one of the most effective means to formulate LNPs for its scalability and reproducibility. Explore LNP formulation, polishing, sterile filtration of mRNA-LNPs, and more.
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![mRNA GettyImages-1356994684]( "Levers To Optimize The IVT Reaction For Increased mRNA Yield")
Mastering IVT yield requires balancing magnesium and nucleotide ratios. Learn how specific buffers and pyrophosphatase optimize mRNA synthesis for scalable, high-quality therapeutic production.
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![GettyImages-96310150-microfluidics.jpg]( "Getting Genomic Medicines Ready For Prime Time")
Explore the benefits of building a manufacturing process early, how research into LNPs in nucleic acid therapeutics will contribute to the development of future drugs, and more.
