MANUFACTURING ARTICLES
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The Delivery Challenge For In Vivo Cell Engineering
As 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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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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Nucleic Acid Ligases: Connecting The Pieces For Sustainable And Scalable Production Of Oligonucleotide Therapeutics
Chemoenzymatic ligation could overcome the scalability and sustainability limits of traditional oligonucleotide manufacturing, enabling more efficient RNA drug production.
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Soliman Says… 5 Questions Every RNA Platform Must Answer Before Investors Write The Check
A practical framework for evaluating whether an RNA company has the science, strategy, scalability, and discipline to become a lasting platform.
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Building A Self-Driving Lab For LNP Development
With commercially available components, MIT researchers built a platform that accelerates LNP process development, optimization, and autonomous manufacturing research.
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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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Take a step-by-step review of the mRNA therapeutics journey and find out how you can meet the critical process, scale, quality and regulatory needs from development to commercialization.
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HS 2022 has 351 sets of modifications covering a wide range of products, introducing significant improvements to the Harmonized System, which will be used to update tariff systems with participating countries.
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Prioritize operational efficiency over early-stage flexibility to scale advanced therapies. Standardized workflows and qualified shipping lanes reduce variability for predictable late-phase success.
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This poster shows the work to scale up COVID-19 self-amplifying RNA-Lipid nanoparticle using PNI developed ionizable lipid and formulation from 0.2, to 50 mg scale using PNI’s Manufacturing Platform.
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Here, we describe the use of a custom-designed cost model to explore the economics of vaccine manufacturing when using different modalities.
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Understanding how to fine-tune pH and ionic strength allows for the detection of truncated sequences and single-nucleotide variants, turning complex purification challenges into reproducible data.
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Cell & gene therapies are rapidly outpacing the industry's limited manufacturing capacity. Learn more about the developing network of supply chain centers built to support this growing client base.