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
Meet our ÄKTA oligosynt™ oligonucleotide synthesizer – a small system with a big impact up to 12 mmol.
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.
Achieve seamless purification scale-up from development to manufacturing using integrated chromatography and TFF systems. Optimize workflows, ensure batch consistency, and accelerate time to market.
Stay ahead in mRNA therapeutic development by mastering the essential quality systems, process controls, and analytical methods required for robust GMP production and efficient manufacturing.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1731147638 research, cell culture]( "Enhanced mAb Production With High-Intensity Perfusion CHO Medium")
Reach new heights in mAb production with a high-intensity perfusion CHO medium designed to support consistently high product yield and quality in continuous perfusion cultures using CHO-K1 cells.
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![GettyImages-1363605023-technician-equipment-technology-cleanroom]( "A Shift Towards Biofluorescent Particle Counters In Manufacturing")
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.
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![iStock-1125935859-logistics-supply chain-shipping-transportation]( "2022 Updates To The Harmonized System (HS) And Harmonized Tariff Schedule (HTS)")
HS 2022 has 351 sets of modifications covering a wide range of products, introducing significant improvements to the Harmonized System, which will be used to update tariff systems with participating countries.
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![GettyImages-1319439243-dna-gene-therapy-helix]( "Genomic Medicine Demands Manufacturing Innovation")
The promise of novel therapeutic modalities can only be realized when effective science is paired with efficient manufacturing to provide cost-effective therapies to patients in need.
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![GettyImages-1275317360-lab-cell-gene-research-scientist-development-discovery]( "Scale-Up And Manufacturing Of Self-Amplifying RNA-LNPs")
This poster shows the work to scale up COVID-19 self-amplifying RNA-Lipid nanoparticle using PNI developed ionizable lipid and formulation from 0.2, to 50 mg scale using PNI’s Manufacturing Platform.
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![Benefits Of Preventative]( "Benefits Of Preventive Maintenance For Pharma Manufacturing")
Preventive maintenance helps reduce equipment failures. Learn why regular service schedules are becoming even more important as biopharmaceutical production shifts toward continuous processing.
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![GettyImages-533059254-rna-dna-strand-light]( "Optimizing siRNA Therapeutics: Addressing Manufacturing Complexities")
Discover key strategies to optimize siRNA therapeutics by addressing critical nonclinical and manufacturing challenges for a smoother path to commercialization.
