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
We all know that plasmid quality is foundational in dictating the quality of the final mRNA drug substance. In this clip homing in on upstream process considerations, speakers Stu Sundseth (Tune Therapeutics), Marc Wolfgang (Sail Biomedicines), and Christian Dohmen (Ethris) outline some of the most important CQAs for plasmids and the impact they can have on the resulting quality of the mRNA drug substance for linear mRNA.
What is Bio-Layer Interferometry (BLI)? Watch to learn about BLI and the advantages of utilizing a proven BLI platform.
Learn how flexible facility design and process innovation are accelerating pDNA manufacturing, as well as key strategies to avoid scale-up pitfalls and meet growing therapeutic demand.
Cell & Gene: The Podcast Host, Erin Harris, welcomes Romesh Subramanian, Ph.D., CEO of Ascidian Therapeutics, a Boston-based biotech focused on rewriting RNA to the pod. During the episode, Subramanian defines RNA exon editing, and they discuss the differences between RNA exon editing and gene editing. With current programs in ophthalmology, neurological and neuromuscular disorders, as well as rare diseases, Subramanian explains the overwhelming potential of RNA exon editing.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1279969622-self-injector-injection]( "Manufacturing Challenges With High Concentration Biologics")
Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.
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![GettyImages-96310150-microfluidics.jpg]( "Accelerated Development Of Self-Amplifying mRNA (saRNA) Vaccines Using Microfluidics")
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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![KNAUER - Azura]( "The Hitchhiker´s Guide To Creating Oligonucleotides From Start To Finish")
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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![Genomic sequencing, molecular biology, and genetic data analysis-GettyImages-2153790378]( "The Paradigm Shift: From Scale-Up To Scale-Out In Genetic Medicine")
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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![GettyImages-1371707479-lab-mask-team-partnership]( "mRNA/saRNA Manufacturing RNA Program Development & Support")
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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![GettyImages-542935478-lab-development-research]( "Oligo-Ready")
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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![GettyImages-1087219366-filling-vials-mechanical]( "How Robotic Isolator Technology Aligns To Annex 1 Principles")
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.
