MANUFACTURING ARTICLES
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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.
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![Cellular gas photo]( "Beyond Vaccines: Can RNA Sense Gases?")
Beyond Vaccines: Can RNA Sense Gases?Could RNA sense its environment? A new hypothesis explores how RNA may detect temperature and gases, inspiring smarter, adaptive RNA therapeutics.
MANUFACTURING VIDEOS
In this Advancing RNA Live clip, Sanofi’s Sumit Luthra highlights the learnings we’ve made to-date about how our processes — both in terms of unit operations and process conditions — inform our LNP composition/heterogeneity.
As Pfizer and Moderna publicly announce work on an mRNA-based universal flu vaccine, what else is on the horizon for mRNA? Tune in to this segment from the Bioprocess Online Live event mRNA Manufacturing: Bright Future, Big Challenges for a discussion with Roberta Duncan, VP of the mRNA program at Seqirus; Duke Human Vaccine Institute Associate Director of Upstream and Downstream Process Development Jason Dickens, Ph.D.; and Jin Zhou, Executive Director of Process Development for mRNA and Protein Biologics at Ultragenyx. In this clip, they share market forecasts for mRNA vaccines and therapeutics and their companies’ go-forward plans to meet those demands.
Cell & Gene: The Podcast Host, Erin Harris, welcomes Romesh Subramanian, Ph.D., CEO of Ascidian Therapeutics, a Boston-based biotech focused on rewriting RNA to the pod. During the episode, Subramanian defines RNA exon editing, and they discuss the differences between RNA exon editing and gene editing. With current programs in ophthalmology, neurological and neuromuscular disorders, as well as rare diseases, Subramanian explains the overwhelming potential of RNA exon editing.
Nutcracker Therapeutics’ Oreanna Thomas shares her takeaways from a pre-IND meeting for one of the company’s mRNA therapeutic candidates.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1622519985 cryopreservation, cold chain]( "Regulatory Readiness Is Built Early")
Building regulatory readiness early in cell and gene therapy development protects product integrity, prevents costly delays, and secures long-term program viability.
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![GettyImages-515631085-cryopreservation-cryo-cold]( "Expand Trial Footprints Without Expanding Cryopreservation Risk")
Transitioning from fresh to frozen starting material stabilizes cell therapy inputs, but isolated workflows introduce risk. Integrated logistics safeguard quality as trial footprints expand.
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![Modern Medical Laboratory, biotechnology research-GettyImages-2266784532]( "When Local Variation Becomes Global Risk In Phase III")
Late-stage therapy trials demand strict execution. Learn how local handling variations escalate into global risks and how early standardization safeguards therapeutic integrity and compliance.
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![GettyImages-1293772880-Lab-Science-Research-Scientist-Discovery-Development]( "From Data To Decisions: Accelerating Your mRNA Drug Development With Analytics")
To stay ahead in the competitive landscape of mRNA development, adopt a comprehensive QC strategy today and begin conducting meaningful tests to ensure the quality of your test articles.
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![GettyImages-1295693748-mRNA]( "Addressing Challenges In mRNA Drug Development And Manufacturing")
mRNA-based drug products serve as an ideal platform for use in infectious disease, protein replacement, and immuno-oncology applications due to the simplicity of manufacturing and robust immune response.
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![Implementing Continued Process Verification Feature]( "How To Automate Continued Process Verification")
This eBook describes automation of continued process verification and offers a one-click solution for statistical trending of data, campaign reports, and annual product quality review.
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![GettyImages-1333406903-liquid-nitrogen-cryopreservation-cold-chain]( "Accelerate Efficiency By Decoupling Collection From Manufacturing")
Cryopreservation eliminates rigid timelines by decoupling collection from production, providing the flexibility needed to optimize facility use and stabilize advanced therapy supply chains.
