MANUFACTURING ARTICLES
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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.
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![Antibody-oligonucleotide conjugates or AOC-GettyImages-1826415365]( "Nucleic Acid Ligases: Connecting The Pieces For Sustainable And Scalable Production Of Oligonucleotide Therapeutics")
Nucleic Acid Ligases: Connecting The Pieces For Sustainable And Scalable Production Of Oligonucleotide TherapeuticsChemoenzymatic ligation could overcome the scalability and sustainability limits of traditional oligonucleotide manufacturing, enabling more efficient RNA drug production.
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![Pen being used to write a check-GettyImages-173602091]( "Soliman Says… 5 Questions Every RNA Platform Must Answer Before Investors Write The Check")
Soliman Says… 5 Questions Every RNA Platform Must Answer Before Investors Write The CheckA practical framework for evaluating whether an RNA company has the science, strategy, scalability, and discipline to become a lasting platform.
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![Small interfering RNA, sirna, mrna, crispr-GettyImages-1409578453]( "Building A Self-Driving Lab For LNP Development")
Building A Self-Driving Lab For LNP DevelopmentWith commercially available components, MIT researchers built a platform that accelerates LNP process development, optimization, and autonomous manufacturing research.
MANUFACTURING VIDEOS
This Advancing RNA Live clip dives into the biggest challenges in mRNA purification and the critical debate on where to focus investment. Here, our three mRNA PD experts argue for a holistic process development strategy, challenging the traditional wisdom of optimizing the upstream process at any cost.
Though there are a lot of exciting advancements being made with novel lipid chemistries, CMC Consultant Sujit Jain provides an important reality check for us: These innovations break established platforms, requiring fresh process development, complex impurity profiling, and new vendor qualifications.
Multiple steps in the mRNA manufacturing process can appear more complex than they have to be. Learn how to simplify your approach and produce the best possible mRNA vaccines and therapeutics.
In this Advancing RNA Live clip, CMC Consultant Sujit Jain explains the numerous ways that adding targeting ligands “stress tests” the standard LNP manufacturing platform, as well as outlines which capabilities are most important for companies to consider when selecting an outsourcing partner for their active delivery strategies.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Multicolored antibodies immunoglobulin protein structures-GettyImages-1301300910]( "Host Cell Protein (HCP) Removal Post Virus Inactivation In mAb Processing")
Clarifying post–virus inactivation streams with a charged depth filter can remove precipitates while significantly reducing HCPs. See how a dual‑layer filtration approach supports stronger impurity control.
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![GettyImages-506999858-scientists-cell-culture-lab-development]( "Optimization And Scale-Up Of A Plasmid DNA Production Process")
Optimizing pDNA production in E. coli requires strategic media selection and scale-up planning. Explore a study that identifies ideal conditions for high-yield manufacturing.
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![Integrating Genetic Medicine Into Clinical Care]( "Optimization Of Transient Transfection Of MSCs With Plasmid DNA Or mRNA")
Read through the results of our efforts to produce an optimal protocol for the transient transfection of hMSCs with pDNA or mRNA using non-viral means.
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![GettyImages-1368058797 vial, fill finish]( "Key Topics And Trends In Aseptic Filling")
Aseptic filling is vital yet often guided by outdated practices. Discover expert insights on modern technologies, evolving regulations, and data-driven strategies to improve compliance and reduce risk in this critical manufacturing step.
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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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![GettyImages-2164544328-man-biotech-hand-blue]( "Scaling For What's Next In EMEA")
Scaling cell and gene therapy operations in EMEA demands strategic planning, regulatory alignment, and robust logistics to meet growing demand and ensure consistent delivery across diverse markets.
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![GettyImages-1443323134-digital-binary-code-artifical-intelligence-robotic-hand]( "Digital Twins And Mechanistic Models For Optimized Bioprocessing")
Integrating AI and having a robust IT infrastructure is crucial for modernizing your processes. Discover how digital twins and mechanistic modeling are revolutionizing biomanufacturing, enhancing efficiency, and reducing costs.
