MANUFACTURING ARTICLES
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![Future business concept-GettyImages-1390149628]( "5 Critical Regulatory Topics To Watch In The Oligo Sector")
5 Critical Regulatory Topics To Watch In The Oligo SectorThough 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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![DNA target nanodrugs-GettyImages-1405926704]( "Beyond Gene Silencing: Harnessing Regulatory RNAs To Increase Gene Expression In Haploinsufficient Disease")
Beyond Gene Silencing: Harnessing Regulatory RNAs To Increase Gene Expression In Haploinsufficient DiseaseCan RNA therapeutics increase — not silence — gene expression? Regulatory RNA-targeting ASOs may redefine treatment for haploinsufficient diseases.
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![Small interfering RNA, sirna, mrna, crispr-GettyImages-1409578453]( "Beyond The m⁷G Cap: How Non-Canonical RNA Capping Could Expand RNA Therapeutics")
Beyond The m⁷G Cap: How Non-Canonical RNA Capping Could Expand RNA TherapeuticsNewly 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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![AI, artificial intelligence, dna research-GettyImages-2192601384]( "Bridging The Atlantic: A European Executive's Guide To Entering The U.S. RNA Market (Pt. 1)")
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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![DNA holographic floating at lab Salubrious-GettyImages-2221232296]( "Patenting RNA Therapeutics In The Age Of AI: What Companies Must Get Right Early")
Patenting RNA Therapeutics In The Age Of AI: What Companies Must Get Right EarlyAs AI transforms RNA discovery, companies must rethink inventorship, obviousness, and patent strategy to secure durable intellectual property protection.
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![Mechanism of Antibody-oligonucleotide conjugates or AOC-GettyImages-1826415391]( "Understanding Therapeutic Oligonucleotide Purification By Anion Exchange Chromatography: From Resin Architecture To Process Productivity")
Understanding Therapeutic Oligonucleotide Purification By Anion Exchange Chromatography: From Resin Architecture To Process ProductivityExplore how anion exchange chromatography improves oligonucleotide purification through smarter resin design, better separation, and scalable manufacturing.
MANUFACTURING VIDEOS
An industry expert shares about sustainable Oligo manufacturing approaches that can save time, cost, and resources – while improving purity, quality, and scalability of these promising therapeutics.
In this Advancing RNA Live clip, CMC Consultant Sujit Jain explains the numerous ways that adding targeting ligands “stress tests” the standard LNP manufacturing platform, as well as outlines which capabilities are most important for companies to consider when selecting an outsourcing partner for their active delivery strategies.
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.
In this Bioprocess Online Live panel, we discuss two experts' perspectives on the current state of the mRNA supply chain for critical raw materials and manufacturing supplies and where pain points still exist.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-523692032]( "Moderna's Regulatory Journey: 3 Takeaways To Foster The mRNA Renaissance")
The story of how Moderna brought one of the first mRNA vaccines to the market has all the makings of a legend we will pass down through generations. However, unlike the legends of King Arthur or The Fountain of Youth, we can celebrate that Moderna’s legendary journey was — and still is — real. Not only did the mRNA vaccines help return life to normal, but they also kickstarted the mRNA therapeutic renaissance we’re happily experiencing today.
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![SA25-Aseptic-Filling-Workcell-interior-5]( "Standardization And Flexibility In Aseptic Filling")
Standardization and flexibility in aseptic filling were thought to be mutually exclusive. But what if there was a standardized system with flexibility built into the aseptic process, so you didn’t have to choose?
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![GettyImages-877873518 cell and gene future]( "State Of The Industry: 2023 Predictions With Dr. Mark Sawicki")
As cell and gene therapies experience accelerated growth this year, learn more about persisting obstacles for patients and the logistical innovations poised to expand access to life-saving therapies.
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![GettyImages-2017789595 lab, research]( "Essential Strategies For IVT Optimization")
Optimizing in vitro transcription (IVT) for mRNA is crucial to improving the stability of these molecules and enabling their large-scale production.
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![GettyImages-1356994684-epigenetics-rna]( "Understanding mRNA Technology As A Platform For Biopharma")
Explore the advantages of mRNA technology, the process steps of large-scale mRNA production, and the effect of common contaminants on mRNA manufacturing.
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![Scientists in lab-GettyImages-1441665026]( "Strategize For Success With Single-Use Biomanufacturing Systems")
Single-use technologies are reshaping biomanufacturing workflows. Discover the key stages of implementation and how strategic choices drive success across the entire production process.
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![GettyImages-1356993441 mRNA]( "mRNA Purification Using Anion Exchange Chromatography At Ambient Temperature")
Explore how anion exchange chromatography with dual gradient elution enables efficient mRNA purification at ambient temperature.
