MANUFACTURING ARTICLES
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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.
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Patenting RNA Therapeutics In The Age Of AI: What Companies Must Get Right Early
As AI transforms RNA discovery, companies must rethink inventorship, obviousness, and patent strategy to secure durable intellectual property protection.
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Understanding Therapeutic Oligonucleotide Purification By Anion Exchange Chromatography: From Resin Architecture To Process Productivity
Explore how anion exchange chromatography improves oligonucleotide purification through smarter resin design, better separation, and scalable manufacturing.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.
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We showcased the utility of microfluidics to enable low shear, rapid screening of preclinical candidates and the swift advancement to GMP-enabling studies.
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Producing high-quality oligonucleotides demands precise execution across multiple stages. Gain a clearer understanding of the complete mid-scale production workflow and necessary quality control measures.
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The shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.
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Venkata Indurthi, Ph.D., shares his knowledge and experience with manufacturing RNA, including key upstream and downstream considerations that go into process development for RNA drug substance manufacturing.
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The benefits of continuous flow manufacturing are significant and numerous and those benefits grow with each technological breakthrough and methodological advance.
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Robotic gloveless isolators provide exceptional automation to eliminate human intervention and reduce contamination risk. Discover how they ensure compliance with the EU Annex 1 guideline to enhance sterility, precision, and monitoring.