MANUFACTURING ARTICLES
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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.
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![GettyImages-1494348289_lab microscope]( "The Delivery Challenge For In Vivo Cell Engineering")
The Delivery Challenge For In Vivo Cell EngineeringAs RNA therapies expand beyond the liver, delivery—not payload design—has become the defining challenge for precise, scalable in vivo cell engineering.
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![GettyImages-480155972_Leukodystrophy]( "Building An ASO For TUBB4A-Related Leukodystrophy (Pt. 1)")
Building An ASO For TUBB4A-Related Leukodystrophy (Pt. 1)SynaptixBio CEO Dan Williams explains how the company selected an ASO for TUBB4A leukodystrophy by balancing potency, safety, and translational rigor to advance a rare disease therapy.
MANUFACTURING VIDEOS
LNPs made using Helix Biotech's Nova BT IJM manufacturing system.
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.
Hosted by Cell & Gene Collaborative's Director Anna Rose Welch, ARW on RNA puts a creative spin on the emerging mRNA + RNA therapeutics industry. Here, in Episode 3, Welch explores the similarities that exist between the art of crafting a high quality violin and the upstream process development work mRNA therapeutics experts are performing today to create the most ideal mRNA drug substance.
While we can make lots of mRNA at a smaller scale, when it comes to scaling up to kg quantities of mRNA, our current batch processes leave a lot to be desired. Together, Stu Sundseth of Tune Therapeutics and Christian Dohmen of Ethris unpack the biggest barriers to scaling IVT to achieve the desired yield and quality of mRNA, offering their take on how the field is innovating to overcome these issues.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1622519985 cryopreservation, cold chain]( "Optimizing Leukapheresis Cryopreservation For CGT")
Discover how an automated cryopreservation process is reshaping the leukapheresis supply chain and driving progress in the future of cell and gene therapy.
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![GettyImages-1224202684-laboratory-dna-scientist-research-monitoring]( "Sample Quality Control In Next-Generation Sequencing Workflows")
See how automated electrophoresis and key integrity metrics strengthen NGS workflows by improving sample assessment, streamlining QC steps, and supporting confident decisions.
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![Scientist Laboratory sample pipette GettyImages-1354172647]( "Sequencing Of Synthetic Oligonucleotides And Their Impurities")
We demonstrate an automated, compliance-ready liquid chromatography-mass spectrometry (LC-MS) workflow for sequence confirmation of oligonucleotides and their impurities.
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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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![Handshaking-GettyImages-537252274]( "Communication And Transparency In Secondary Supply Qualification")
What should you look for when searching for the right vendor to help you maintain security of raw materials and how can you establish communication that builds confidence?
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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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![risk]( "Aseptic Process Sampling Risk Mitigation – A Regulatory Perspective")
This overview outlines regulatory guidelines for sampling, examines the limitations of conventional methods, and emphasizes the advantages of aseptic, single-use approaches in achieving compliance.
