FORMULATION ARTICLES
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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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![vaccine, vaccination, virus dna doubts questions-GettyImages-1308261360]( "The Hidden Language Of RNA: How lncRNA-Splicing Networks Are Redefining The Future Of Therapeutics")
The Hidden Language Of RNA: How lncRNA-Splicing Networks Are Redefining The Future Of TherapeuticsLong non-coding RNAs and splicing networks are emerging as master regulators of cellular identity, opening new therapeutic opportunities beyond proteins.
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![Ribosome as part of an biological cell constructing mRNA molecule-GettyImages-1352440312]( "RNA-Binding Proteins As Architects Of Post-Transcriptional Control In Disease Biology")
RNA-Binding Proteins As Architects Of Post-Transcriptional Control In Disease BiologyRNA-binding proteins orchestrate splicing, stability, localization, and translation, emerging as powerful regulators and therapeutic targets in disease.
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![Emergency medicine-GettyImages-2055655561]( "Targeting The Uncharted Heart: Why The Next Era Of siRNA Belongs In Cardiology")
Targeting The Uncharted Heart: Why The Next Era Of siRNA Belongs In CardiologyDuring our conversation, Gallagher walked me through what’s keeping her up at night as she leads the company and its first siRNA candidate toward an IND, elaborating on the role RNA can play in cardiomyopathies and identifying the unique challenges of developing RNA medicines today.
FORMULATION VIDEOS
mRNA therapeutics are applicable to cancer immunotherapies, infectious diseases, and other indications that require protein replacement therapy or antibodies.
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.
It goes without saying that achieving cell-specific delivery is the most often discussed challenge facing the RNA-LNP field near- and long-term. However, as these three LNP experts share in this Advancing RNA Live clip, they have a whole list of additional R&D and CMC priorities we must address/accomplish to improve RNA-LNPs’ efficacy in personalized and gene therapy approaches.
Explore constructing a modular RNA-LNP GMP facility using Cytiva's FlexFactory™ process train in a KUBio™ environment to scale RNA-LNP therapies.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![nanoparticles-drug molecule-GettyImages-1428647836]( "Accelerate LNP Manufacturing With Automated Process Development")
Manual LNP formulation introduces process variability that threatens particle quality and yield. As programs scale toward clinical production, maintaining strict control over CQAs becomes essential.
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![GettyImages-851771510-eye-futuristic-scanning]( "Ophthalmic Drug Delivery")
Explore the challenges to effective delivery of drugs to the eye, intricacies of ophthalmic drug delivery, and advantages of nanoparticles as an enabling technology for ocular drug-delivery systems.
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![GettyImages-1287846309-research-lab-computer-graph-data]( "Low-Volume Production For Screening High-Value Nanoparticle Materials")
A platform that harnesses microfluidic mixing has been demonstrated as a simple, robust, and scalable production method for LNPs encapsulating various types of nucleic acids.
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![Medical scientists analyzing research-GettyImages-1413600685]( "Developing A Comprehensive Regulatory Approach For LNP Drugs")
The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.
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![MSglassvials]( "Supporting Complex Manufacturing For Liquid And Lyophilized Drug Products")
Aseptic fill and finish operations gain efficiency and precision with modular isolator technology, inline weight checks, and lyophilization, which are ideal for mRNA-LNPs and other sensitive modalities.
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![Science techonlogy-research-development-discovery-GettyImages-1209662272]( "Turbulent Mixing: Scaling Up Nanoparticle Manufacturing For The Future")
Choosing between turbulent and microfluidic mixing methods in your lipid nanoparticle (LNP) production can have a significant impact when scaling up production.
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![GettyImages-508496956-dna]( "mRNA: Challenges And Strategies Related To The DNA Template Process")
Encapsulated mRNA–LNP creation begins with synthesizing the DNA template. Explore insights on DNA template synthesis, the challenges and strategies of generating a DNA template using PCR, and more.
