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
Examine why template sequence characteristics are relevant for cGMP manufacturing of high-quality mRNA and consider insights on how to develop a scalable, robust, and economically viable process.
Nutcracker Therapeutics is a preclinical biopharma company developing multimodal RNA-based therapeutics for HPV-driven tumors, T-cell lymphoma, and Genitourinary tumors. On this episode of the Business of Biotech, Chief Business Officer Geoff Nosrati, Ph.D. offers a comprehensive view of the RNA-based therapeutics landscape and sheds light on what he perceives as an advantageous position at Nutcracker — the capacity to manufacture RNA in-house. If you're curious about the expanding science behind RNA-based therapeutics and their application in biotech, this conversation with a scientist-turned-chief business officer (Nosrati earned his Ph.D. in Biochemistry and Molecular Biology) is a can't-miss episode.
Built on our revolutionary NxGen™ technology found in our NanoAssemblr® family of instruments, NanoAssemblr® GMP System enables you to go from concept to clinic with speed and confidence.
Explore how next-gen technologies, from mRNA platforms to digital tools, are transforming vaccine manufacturing to make it more sustainable, flexible, and accessible.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-2190246741 lab]( "Phase-Appropriate Approaches To Manufacturing And Testing")
Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.
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![Getty Images-823447656-vector-viral-lab-AAV-cell-development]( "CAR T Set The Pace So All Can Win The Cell Therapy Race")
Gain insight into the modest origins of cell therapy manufacturing and how this history has paved the way for future advancements from Bill Shingleton, R&D Leader at Cytiva.
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![GettyImages-1360244592-frozen-organ]( "Where Innovation Is Moving The Advanced Therapies Supply Chain")
Assimilate how advanced therapy supply chains are evolving toward patient-centric, risk-managed, digitally connected models to support scale, reliability, and regulatory confidence globally today.
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![GettyImages-1300035668-nanoparticle-particle]( "Lipid Nanoparticle Development, Manufacturing Advance Novel Therapeutics")
An effective partner must possess the necessary unique analytical capabilities for LNP characterization and the ability to support clients from concept to commercialization.
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![Sartorius CIM HIP Plasmid Process PackTM, CIMac pDNA]( "In-Process Control Of pDNA Production On CIMac™ pDNA Analytical Column")
As the demand for plasmid DNA (pDNA) based gene therapy and vaccines increases, large-scale, cost-effective, and reproducible pDNA production is required. The key to success is a real-time in-process control method that ensures a high percentage of supercoiled pDNA in the final product. Read how the CIMac™ pDNA Analytical Column allows the monitoring of degradation products (open circular and linear pDNA), the removal of impurities (RNA), and ensures that each production step yields the amount of supercoiled pDNA anticipated.
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![GettyImages-1295693748-mRNA]( "Current And Emerging Technologies To Optimize mRNA Manufacturing")
Explore the benefits of using mRNA for vaccines and therapeutics, and learn how to address technical, intellectual property, and cost considerations when considering commercial production.
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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.
