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
Innovation and invention are often limited by challenges in deployment. Here, Cell & Gene Live’s panelists, Nathaniel Wang, CEO and Co-Founder, Replicate Bioscience and Sam Deutch, EVP of Research and Early Development at Nutcracker Therapeutics detail how is the field solving these issues. They cover how evolution in the scale up production of novel engineering technologies impacts their near term and long-term deployment.
In this final segment of an Advancing RNA Live discussion, panelists April Sena, Tyler Goodwin, and Adi Nair share the most meaningful and manageable improvements the industry can be making today to upstream and downstream processes to drive down mRNA-LNP COGS.In this final segment of an Advancing RNA Live discussion, panelists April Sena, Tyler Goodwin, and Adi Nair share the most meaningful and manageable improvements the industry can be making today to upstream and downstream processes to drive down mRNA-LNP COGS.
Explore the features of this benchtop system including the dual pump module, mixer module, collection module, software, and additional features.
Sanofi’s Sumit Luthra shares several of the analytical and manufacturing innovations/improvements he’s watching and waiting for that will improve our knowledge of LNP composition, structure, function, and quality.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1313742092 tech partner]( "The Execution Stage Of Technology Transfer")
What are the key elements in the readiness stage of a technology transfer that are critical to your success? Explore Process Performance Qualification (PPQ) and the execution stage of PDA TR-65.
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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-2189138619 lab]( "5 IVT Design Considerations Before Scale-Up")
As RNA programs advance toward clinical manufacturing, five IVT design questions can help teams identify hidden process risks before scale-up exposes them.
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![GettyImages-1648451263 Scientist Holding Tray Of Medical Samples In Lab]( "Continuous Nanoparticle Manufacturing For Gene Editing Delivery")
Messenger RNA-LNPs are a promising strategy for delivering gene-editing components. Learn how a continuous manufacturing platform can address the scalability and reproducibility challenges of this process.
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![data-clinicial-GettyImages-2185301670]( "Why Your Bioanalysis Bottleneck Is Costing You More Than You Think")
This piece explains why turnaround time is a strategic variable, where speed is truly achievable, and how automation reshapes the path from sample submission to decision‑ready data.
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![Molecular Genetic Therapy iStock-1289215513]( "How Tools And Technologies Bring Advanced Therapies To Market")
Gain insight into industry trends and the tools to support the development of RNA vaccines and therapeutics.
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![GettyImages-2270210340-lipid-nanoparticle-delivery-system]( "Extrahepatic Delivery Of mRNA-LNP To Spleen")
In vivo CAR-T approaches aim to reprogram T cells directly in the body using targeted lipid nanoparticles. Improved delivery to immune organs highlights new potential for scalable cell therapies.
