MANUFACTURING ARTICLES
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![Scattered thoughts-GettyImages-2178092695]( "The Hidden Bottleneck In Advanced Therapies Isn't Science… It's Translational Friction")
The Hidden Bottleneck In Advanced Therapies Isn't Science… It's Translational FrictionScientific breakthroughs may spark innovation, but operational excellence ultimately determines which advanced therapies reach patients.
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![DNA target nanodrugs-GettyImages-1405926704]( "RNA Therapeutics: Why CMC Strategy Will Define The Next Decade")
RNA Therapeutics: Why CMC Strategy Will Define The Next DecadeAs RNA matures into an industrial platform, long-term success will depend less on discovery and more on scalable CMC systems, integration, and execution.
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![AI Medical Technology-GettyImages-2242544252]( "Rethinking The Oligonucleotide Backbone: Why RNA Therapeutics May Need A New Molecular Design Framework")
Rethinking The Oligonucleotide Backbone: Why RNA Therapeutics May Need A New Molecular Design FrameworkNew backbone chemistries could unlock greater control over delivery, specificity, and safety, expanding the molecular design space for RNA medicines.
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![Virology, infectious diseases, virus diagnostics, virus research, biotechnology-GettyImages-2219621039]( "RNA Platforms: What Transfers And What Breaks")
RNA Platforms: What Transfers And What BreaksA practical framework for distinguishing reusable RNA platform knowledge from biology-specific unknowns as therapeutics expand into new tissues and indications.
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![Burrowing owl-GettyImages-964611070]( "Stay \"Stereocurious\": What The Future Holds For Oligo Quality")
Stay "Stereocurious": What The Future Holds For Oligo QualityOverall, there were two areas of discussion at TIDES that demonstrate the amount of growth we have yet to do as a space — particularly in the realms of regulatory development and quality. As I intend to showcase here in part 1 of this muti-part article, this year’s TIDES was a great reflection of the tension(s) that can arise as we realize how much space exists between where we are and where we’re going next.
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![RNA, siRNA, mRNA, CRISPR-GettyImages-1409578455]( "Scaling RNA Therapeutics: Purification, LNP Formulation, And GMP Manufacturing (Pt. 2)")
Scaling RNA Therapeutics: Purification, LNP Formulation, And GMP Manufacturing (Pt. 2)Part 2 explores the downstream technologies that turn RNA into a therapeutic product, from impurity removal and LNP formulation to GMP infrastructure and scalable manufacturing.
MANUFACTURING VIDEOS
In this Advancing RNA Live clip, Sanofi’s Sumit Luthra highlights the learnings we’ve made to-date about how our processes — both in terms of unit operations and process conditions — inform our LNP composition/heterogeneity.
In this segment of an Advancing RNA Live panel discussion, experts from Life Edit Therapeutics, Tune Therapeutics, and University of Sheffield share their perspectives on the role automation and digital tools (i.e., soft sensors, digital twins can play in helping us better control our manufacturing processes.
Explore the future of nucleic acid and nanoparticle-based therapeutics, including mRNA, CRISPR, and gene editing, as experts discuss innovative solutions for complex health challenges.
Discover a compact, fully automated oligonucleotide synthesizer for robust, scalable process development. Learn how it can help establish a robust and reproducible oligo synthesis process.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1437856375-lnp-lipid-nanoparticle]( "The Crucial Role Of Downstream Processing In Optimizing RNA-LNP Drug Development")
Explore the key aspects of lipid nanoparticle (LNP) development, including the essential downstream processes of Tangential Flow Filtration (TFF) and normal flow filtration.
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![GettyImages-1324966781-mrna-vaccine-covid-coronavirus]( "Addressing And Adapting To Evolving mRNA Market Trends")
Pierre Catignol and Huisub Lim share their insights on current mRNA market trends, manufacturability, choosing an appropriate CDMO partner, and mRNA technology considerations.
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![GettyImages-1219169373 lab, research, assay, RNA, DNA]( "A Multiplexed High Throughput Method To Evaluate Novel Nuclease Activity")
Efficiently evaluating the activity of novel nucleases with unique properties requires a high-throughput, multiplexed approach that enables direct comparison across multiple genomic targets.
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![GettyImages-1288118586 cell development]( "Expectations On The Pathway To GMP For Gene-Modified Cell Therapies")
Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
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![mRNA GettyImages-1428646288]( "mRNA Synthesis Reagents And Manufacturing")
As novel mRNA therapies are starting to enter clinical stages of development, Aldevron is providing critical support in a number of ways with specialized products and services.
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![QA-Quality Assurance-GettyImages-1184320070]( "5 Areas To Focus Your QRM Strategy For Sterile Drug Products")
Explore five areas that can form part of a quality risk management strategy to ensure the compliant manufacturing of sterile drug products.
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![bacterial colonies for pDNA cloning iStock-180342961]( "Comparison Of HIC Monolithic Support For Sample Displacement Chromatography Of pDNA")
Competing adsorption in sample displacement chromatography utilizes the chromatographic resin's binding capacity more efficiently and increases the chromatographic step's productivity. This application note investigates three monolithic chromatographic supports with different hydrophobicities regarding their applicability for sample displacement of pDNA. CIMac™ C4 HLD (butyl, high ligand density) as a commercial product and pyridine and histamine as custom immobilised columns are compared.
