MANUFACTURING ARTICLES
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![intelligent technology interface, robot chat-GettyImages-2279572840]( "Analytical Platforms: The Foundation Of The Next Generation Of RNA Therapeutics")
Analytical Platforms: The Foundation Of The Next Generation Of RNA TherapeuticsRNA therapeutics are entering a new era where analytical platforms drive scalability, regulatory confidence, manufacturing flexibility, and the development of increasingly complex products.
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![nucleic acid, DNA, RNA, purified protein-GettyImages-1350828873]( "A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA Products")
A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA ProductsNIST research introduces a gentle SEC method that separates dsRNA impurities from IVT mRNA by tweaking buffer pH, achieving 81.8% target recovery without transcript damage.
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![Leukodystrophy Awareness Month-GettyImages-2166836167]( "The Preclinical Gauntlet: Securing Capital And Designing Regulatory Pathways For Ultra-Rare ASO Drugs (Pt. 2)")
The Preclinical Gauntlet: Securing Capital And Designing Regulatory Pathways For Ultra-Rare ASO Drugs (Pt. 2)SynaptixBio CEO Dan Williams explains why funding, regulatory strategy, toxicology, and disciplined execution — not just science — determine success in advancing ultra-rare ASO therapies.
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![MacKay suspension bridge-GettyImages-2281791194]( "Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)")
Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)European RNA biotech leaders can accelerate U.S. success by aligning fundraising, partnerships, manufacturing, hiring, and regulatory strategy from day one.
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![GettyImages-1494348289_lab microscope]( "The Delivery Challenge For In Vivo Cell Engineering")
The Delivery Challenge For In Vivo Cell EngineeringAs RNA therapies expand beyond the liver, delivery—not payload design—has become the defining challenge for precise, scalable in vivo cell engineering.
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![GettyImages-480155972_Leukodystrophy]( "Building An ASO For TUBB4A-Related Leukodystrophy (Pt. 1)")
Building An ASO For TUBB4A-Related Leukodystrophy (Pt. 1)SynaptixBio CEO Dan Williams explains how the company selected an ASO for TUBB4A leukodystrophy by balancing potency, safety, and translational rigor to advance a rare disease therapy.
MANUFACTURING VIDEOS
In this Bioprocess Online Live panel discussion, experts share the most important factors to consider when assessing the manufacturability of novel linear mRNA candidates in order to bring forward the most successful lead candidates.
Discover key upstream and downstream considerations for process development for RNA drug substance manufacturing and the parameters that need construct-specific optimization to increase yield and reduce impurities.
Advancing RNA Live panelists Tyler Goodwin and April Sena start off our latest discussion on technology innovations in mRNA production by surveying the current manufacturing process for plasmid production, highlighting where they’ve seen advancements and what biotechs need to consider to obtain plasmids of the appropriate quality for mRNA production.
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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-163113211-south-africa-globe]( "Building Local Biomanufacturing Capacity In South Africa")
Biovac evolved from a vaccine supplier to a biopharmaceutical innovator, providing a blueprint for expanding Africa's vaccine manufacturing capacity. Gain valuable insights from their journey.
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![GettyImages-919410014-dna-gene-therapy-future-technology]( "Purification Of DNA Oligonucleotides Using An Anion Exchange Resin")
Learn how a strong anion exchange resin can be used for the efficient purification of single-stranded DNA oligonucleotides used in clinical trials.
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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-597935610 cell and gene]( "The Sponsor's Clinical Development Handbook For Gene Therapy Trials")
Gene therapy has existed for decades, but the field is not as mature as it may seem. Here, the author provides essential insights and strategies for overcoming gene therapy development challenges.
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![iStock-1290118109-mrna-vaccine-covid-corona]( "Key Insights Into Overcoming mRNA Process Challenges")
Realizing the potential of mRNA requires focus on key areas and strategies that could help alleviate the bottlenecks in this growing market segment.
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![GettyImages-1317697233-cancer-t-cells]( "A Novel RNA Lipid Nanoparticle Platform: Gene-Edited CAR T Cells For Off-The-Shelf Cancer Therapy")
We report on the use of a novel lipid nanoparticle (LNP) reagent in a validated protocol to achieve successful complex gene editing in primary T cells with high efficiency while maintaining high cell viability.
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![The AutoMate Express Nucleic Acid Extraction System]( "Simultaneous Extraction Of Mycoplasma, MMV, And Vesivirus Nucleic Acids From A Single Sample")
Achieve early detection of cell culture contamination with a nucleic acid extraction system to provide an integrated system for rapid and sensitive detection of mycoplasma, MMV, and vesivirus.
