MANUFACTURING ARTICLES
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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.
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![Green Business-GettyImages-2179499504]( "What Makes An RNA Platform Investable? Lessons From The Last Wave Of Biotech Financing")
What Makes An RNA Platform Investable? Lessons From The Last Wave Of Biotech FinancingRNA investing has shifted from hype to scalability, forcing companies to prove manufacturability, delivery strength, and platform-wide value.
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![new drugs by genome editing-GettyImages-1407089196]( "RNA Manufacturing Foundations: From DNA Templates To In Vitro Transcription (Pt. 1)")
RNA Manufacturing Foundations: From DNA Templates To In Vitro Transcription (Pt. 1)Cell-free RNA production is reshaping biomanufacturing through modular IVT workflows, advanced capping strategies, and scalable DNA template design.
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![Molecular biology, mRNA strands, genetics-GettyImages-2198118160]( "Engineering RNA Payload Distribution In LNPs To Unlock Higher In Vivo Gene Editing Efficiency")
Engineering RNA Payload Distribution In LNPs To Unlock Higher In Vivo Gene Editing EfficiencyNew research shows RNA payload distribution inside LNPs — not just encapsulation efficiency — may be key to unlocking stronger in vivo gene editing performance.
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![Virus, pathogen, bacteria, biotechnology, bacterium, biolaboratory, new X disease, brain illness-GettyImages-1955429813]( "RNA Modification-Mediated Translational Control In Immune Cells")
RNA Modification-Mediated Translational Control In Immune CellsExploring how m6A RNA modifications control immune cell translation, influencing inflammation, tumor immunity, T cell activation, and future immunotherapies.
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![BPO-Modulus-IMG_1]( "Repeating Sanofi's Ballroom Design On Two Continents")
Repeating Sanofi's Ballroom Design On Two ContinentsMoveable walls and a stunning number of robotics at its sites in France and Singapore, among other features, has earned Sanofi international recognition for innovation.
MANUFACTURING VIDEOS
Explore the challenges behind the perceived simplicity of mRNA process development, as well as characterization strategies and models for predicting process outcomes at early stages.
As a field, we’ve been aligned around CQAs for our mRNA drug substances. However, differences in translation between highly similar mRNAs (i.e., (same sequence, same design, different manufacturers) raises the question of whether we’re missing any QAs/CQAs. Here, Advancing RNA Live panelists Elaine Peters and Ilya Shestolapov share their take.
In this Advancing RNA Live clip, CPI’s Claire MacCleod shares the biological and logistical hurdles currently keeping full enzymatic production of siRNA at bay.
Enjoy the flexibility of user-definable parameters, allowing you to tailor each step of your process, including concentration via continuous flow, washing, resuspension, and final formulation.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Manufacturing RNA-containing LNPs demands specialized expertise. Explore some of the challenges of RNA-LNP drug manufacturing and the advantages of outsourcing RNA-LNP formulations.
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![GettyImages-1313742092 tech partner]( "The Execution Stage Of Technology Transfer")
What are the key elements in the readiness stage of a technology transfer that are critical to your success? Explore Process Performance Qualification (PPQ) and the execution stage of PDA TR-65.
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![Virus and Genes iStock-843037718]( "Downstream Process For Gene Therapy, Plasmid-DNA Vaccine Development")
A guide to plasmid DNA downstream process development including clarification, TFF, chromatography, and sterile filtration unit operations.
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![clinical-trial-manager-shakes-hand-1358280580]( "The Source Of GMP- How Client Demand Drives Innovation")
GMP-Source, which is a term we coined, serves the purpose as a highly qualified raw material for a generation of virus, messenger RNA template, and transgenic expression of proteins.
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![GettyImages-1793747580-DNA-double-helix-AI]( "Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer")
Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.
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![GettyImages-1326811027-lab]( "New To mRNA Manufacturing? Considerations For Starting")
Explore considerations for starting mRNA manufacturing related to the following topics: DNA template, mRNA product - IVT, mRNA product - purification, LNP encapsulation, and fill-finish.
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![GettyImages-533059254-rna-dna-strand-light]( "Scalable, Sustainable Support For Next‑Gen Primer Systems")
Explore how an optimized solid‑support design enables higher synthesis scales, steadier pressures, and lower solvent use while preserving yield and purity across diverse oligonucleotide lengths.
