MANUFACTURING ARTICLES
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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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5 Critical Regulatory Topics To Watch In The Oligo Sector
Though our guidances have helped us achieve upwards of 20 commercially approved oligo products, as I listened to GSK’s director of CMC policy and advocacy, Katie Duncan, present at TIDES, it struck me just how far we have yet to come. Here, I single out a few of the biggest topics of regulatory discussion shaping the oligo therapeutics market.
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Beyond Gene Silencing: Harnessing Regulatory RNAs To Increase Gene Expression In Haploinsufficient Disease
Can RNA therapeutics increase — not silence — gene expression? Regulatory RNA-targeting ASOs may redefine treatment for haploinsufficient diseases.
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Beyond The m⁷G Cap: How Non-Canonical RNA Capping Could Expand RNA Therapeutics
Newly discovered non-canonical RNA caps are reshaping RNA biology and could inspire the next generation of more precise, programmable RNA therapeutics.
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Bridging The Atlantic: A European Executive's Guide To Entering The U.S. RNA Market (Pt. 1)
A practical roadmap for European biotech leaders navigating FDA expectations, market entry, and the strategic decisions that shape U.S. expansion.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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What do you need to know before you take your process in-house? A team of experts on nucleic acids therapeutics outlined five key things for you to consider as you make the change.
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Precise enzyme selection in IVT reduces dsRNA byproducts and boosts capping efficiency. This ensures high-quality mRNA production while easing the burden of complex downstream purification processes.
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Here, we demonstrate a scalable workflow for the isolation of exosomes that combines tangential flow filtration for the concentration of exosomes followed by gentle size exclusion chromatography.
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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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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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Learn about the key stages of drug discovery and screening as well as how to overcome bottlenecks in screening mRNA-LNPs to rapidly develop genomic medicines.
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GMP-Source is a more robust, less rigid alternative to full cGMP production that mirrors nearly all of the oversight and quality standards of full cGMP production while relaxing certain commercial standards, helping companies overcome the hurdles that can stall early development.