MANUFACTURING ARTICLES
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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.
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The Future Of RNA Manufacturing: Continuous Processing, AI, And Distributed Production (Pt. 3)
Continuous manufacturing, AI, modular facilities, and next-generation RNA platforms are reshaping how therapies are produced, scaled, and delivered worldwide.
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Can Oligonucleotide Regulations Keep Up With Manufacturing Innovation?
Here in part 2 of my TIDES takeaways, I’ll unpack which guidances we have at our disposal today in the oligo world, and what we can expect in the future.
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Unlocking The Future Of mRNA
Many regulatory frameworks and analytical approaches were not originally designed for platforms like mRNA. Addressing these gaps will be essential to fully realize the potential of mRNA technologies.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Cell therapies, using reprogrammed immune cells, offer innovative treatments for diseases. Discover how lipid nanoparticles (LNPs) enhance these therapies by delivering RNA for gene modulation and next-gen treatments.
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Learn how to separate molecules strictly by size, effectively remove salts, and select the correct pore specifications for a gentle, non-destructive purification workflow.
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Gene delivery platforms must support a diversity of genetic engineering strategies for genomic medicine development. Learn how lipid nanoparticles can accelerate development from discovery to scale-up.
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Here a solution is presented to widely recognized challenges with ionpairing reversed phase liquid chromatography (IP-RP LC) through a novel microflow LC-MS strategy.
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Explore each intertwined step in the mRNA manufacturing process and how a flexible approach can get your mRNA product to clinic and market faster.
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There are two key challenges to realizing the potential of genomic medicines, but potential technological solutions are on the horizon, and we examine each.
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Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.