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
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.
See how Pall innovative and time-saving life science research products simplify and speed up your critical workflow steps and allow for faster data analysis and results.
Learn how single-use technologies deliver important benefits for mRNA manufacturing, including increased speed, quality, flexibility, and adaptability to different dosages and scale-up strategies.
Three regulatory experts share the topics on which they hope to see further agency clarification in the near-term to help mRNA products make meaningful progress toward/through the clinic.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Oligonucleotide Manufacturing: Take Control Of Your Process]( "Oligonucleotide Manufacturing: Take Control Of Your Process")
What do you need to know before you take your process in-house? A team of experts on nucleic acids therapeutics outlined five key things for you to consider as you make the change.
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![GettyImages-2215842270 lab]( "Charged For Action: The Hidden Secrets Of AEX Oligonucleotide Analysis")
Understanding how to fine-tune pH and ionic strength allows for the detection of truncated sequences and single-nucleotide variants, turning complex purification challenges into reproducible data.
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![female scientist working in lab-GettyImages-1867575053]( "xRNA Production: The Economic Case For Continuous Manufacturing")
See how a continuous manufacturing platform streamlines production to days, uses real-time quality control, and dramatically cuts costs to accelerate access to new therapies.
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![GettyImages-1213899382-electrophoresis-pipette-cell-loading]( "Quality Control In IVT RNA Workflow")
Accurate sizing and purity checks are essential in IVT RNA workflows. Explore how automated electrophoresis improves QC efficiency and ensures RNA integrity for downstream applications.
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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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![Lab cell and gene pipette GettyImages-162264253]( "mRNA/saRNA Manufacturing RNA Production & Manufacturing")
Venkata Indurthi, Ph.D., discusses key considerations for the production of RNA and strategies for successful scaling for commercial manufacture. Learn more about messenger RNA and self-amplifying RNA manufacturing processes.
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![GettyImages-1357908552-rna-ribonucleic-acid]( "Expand Your Toolbox For Quality mRNA Manufacturing")
Explore guidelines for the use of SP6 RNA Polymerase in mRNA synthesis and your mRNA production processes.
