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
In this Bioprocess Online Live panel discussion explore how two industry experts encourage their CMC and R&D teams to work more closely together to ensure a streamlined transition of a molecule from R&D to process development.
Learn about a small oligonucleotide synthesizer with big impact that features a user-friendly interface, compact footprint, and more. This small scale system is user friendly and supports scale up.
The TakeOne® is a single-use, pre-assembled sampling device for aseptic collection of samples during upstream and downstream process steps. It is ideal for critical endotoxin, bioburden, sterility and purity checks.
Watch to learn when filter validation should be performed, what is required from an end user and laboratory testing perspective, and how to achieve first-time success for various drug products.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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![iStock-909908830]( "Navigating The Regulatory Maze: Fundamentals For Drug Development")
Learn about key regulatory concepts and ways to accelerate and reduce risk throughout the drug development journey.
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![GettyImages-1327624070-lab-research-development]( "mRNA Manufacturing: Overcoming CMC Development Challenges")
A lack of standardization and cost-effective techniques for manufacturing and analytics for product characterization create CMC challenges for mRNA-based products.
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![GettyImages-1354923731-magnifying-glass-mrna]( "IVT mRNA Encapsulation Efficiency Assessment")
In vitro transcribed mRNA revolutionizes biotherapeutics, which necessitates thorough quality assessments. See how an analyzer system enhances encapsulation efficiency and CQAs in IVT mRNA workflows.
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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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![Molecule mRNA-GettyImages-1428646288]( "Optimized Performance Model For Yield And Quality Of The mRNA Product")
Optimize your mRNA production by identifying an optimum set of conditions for the IVT reaction that produces high-quality mRNA in high yield using a design of experiment (DoE) approach.
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![GettyImages-1327073953 scientist, lab, experiment, biomarker]( "Standardizing Cryopreservation For Cell Therapy Supply Chains")
Explore how a standardized cryopreservation process is transforming leukapheresis handling by reducing risk and improving quality across the cell therapy supply chain.
