FORMULATION ARTICLES
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![Gene editing, gene therapy-GettyImages-930103248]( "Making Personalized Cancer Vaccines Reality: The Manufacturing Challenge Ahead")
Making Personalized Cancer Vaccines Reality: The Manufacturing Challenge AheadPersonalized cancer vaccines are becoming feasible, but scaling fast, affordable, data-driven manufacturing is the central challenge to bringing these individualized therapies to more patients.
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![Multi ethnic lab team-GettyImages-1255978257]( "Strained Manufacturing, Complexity Stymie In Vivo Progress")
Strained Manufacturing, Complexity Stymie In Vivo ProgressExplicitly mapping delivery challenges to the associated GMP process steps converts biological risk into operational risk.
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![Medical syringe with blue glass DNA helix-GettyImages-1631239019]( "To Fight Cancer, Gene Editing Needs To Solve Its Delivery Problem")
To Fight Cancer, Gene Editing Needs To Solve Its Delivery ProblemThe choice of delivery dictates the complexity of manufacturing, which in turn determines the eventual cost and accessibility of the therapy.
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![DNA double helix,Human DNA-GettyImages-1912348507]( "RNA's Evolutionary Logic Is Quietly Rewriting The Future Of Therapeutics: A Conversation With Ahmet Berkyurek")
RNA's Evolutionary Logic Is Quietly Rewriting The Future Of Therapeutics: A Conversation With Ahmet BerkyurekRNA’s adaptive logic is reshaping how therapies are designed. Ahmet Berkyurek explains why embracing evolution—not engineering against it—may unlock the next generation of RNA medicines.
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![Abstract Modern-GettyImages-490280002]( "Rethinking The \"3:1 Rule\" In LNP Production")
Rethinking The "3:1 Rule" In LNP ProductionA new two-step, ideal-mixing strategy from MIT researchers shows how operating briefly in unstable regions of LNP assembly can unlock precise control of particle size and shape—advancing next-gen RNA manufacturing.
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![Tumor microenvironment, cancer cells, t-cells, nanoparticles-GettyImages-1449007926]( "Emerging RNA Delivery Strategies For Solid Tumor Oncology")
Emerging RNA Delivery Strategies For Solid Tumor OncologyRNA shows promise in solid tumors, but delivery remains the core challenge. New targeting and delivery strategies aim to overcome tumor barriers and unlock RNA’s full therapeutic potential.
FORMULATION VIDEOS
In this segment, Replicate Biosciences’ Andy Geall, Qian Ruan, & Alex Aust identify the most promising technological and raw material innovations that are influencing the drug substance and drug product production processes at CDMOs.
Discover key strategies for controlling LNP formulation and upscaling. Explore the science behind lipid nanoparticles, critical parameters, and achieving effective turbulent mixing for optimal outcomes.
In this video, Russell Johnson, VP Formulation Research for RVAC Medicines, and Aalok Shah, Director of Formulation & Drug Delivery, Strand Therapeutics, share their thoughts on the scientific-research and CMC-related reasons that have made the lipid nanoparticle the “darling” of the delivery world for mRNA/RNA products today.
Sanofi’s Sumit Luthra shares several of the analytical and manufacturing innovations/improvements he’s watching and waiting for that will improve our knowledge of LNP composition, structure, function, and quality.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![iStock-1140779660-drug-development-lab]( "Enabling Continuous Manufacturing For CAR-T And LNP-Based Therapies")
Breakthrough therapies are challenged by complex, batch-based manufacturing. A novel, integrated system enables continuous processing, improving consistency and reducing manual handling for advanced modalities.
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![GettyImages-1409578453-mRNA-LNP-lipid-nanoparticle-RNA therapy]( "An Introduction And Brief History Of mRNA-LNPs")
With adjustable components and increased stability during bloodstream circulation, LNPs are significantly advancing drug development and delivery, particularly for mRNA vaccines.
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![Stabilization Of RNA-Loaded Lipid Nanoparticles By Lyophilization]( "Stabilization Of RNA-Loaded Lipid Nanoparticles By Lyophilization")
Discover how lyophilization enhances RNA-based therapeutics by enabling storage at higher temperatures, which simplifies cold-chain logistics while preserving nanoparticle integrity and biological activity.
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![Scientist In Lab GettyImages-1354172647]( "Boost LNP Drug Potency With Optimized Delivery Formulations")
Lipid nanoparticles (LNPs) function as a drug delivery system for nucleic acids. Learn about the biomedical applications of LNPs as well as the anatomy, formulation optimization, and safety of LNPs.
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![GettyImages-2151198847-lipid-nanoparticle-with-rna-strands]( "Advancing Cell Therapies With Lipid Nanoparticles")
Cell therapies, using reprogrammed immune cells, offer innovative treatments for diseases. Discover how lipid nanoparticles (LNPs) enhance these therapies by delivering RNA for gene modulation and next-gen treatments.
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![GettyImages-1751659695-laboratory-scientists-computer-analysis-evaluation]( "CQA Assessment Of LNP-Encapsulated IVT mRNA")
Learn more about issued guidelines on Critical Quality Attributes for IVT mRNA vaccines and biotherapeutics to focus on drug substance and LNP-encapsulated drug product assessment using an analyzer system.
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![mRNA GettyImages-1428646288]( "Early Spectroscopic Insights Into RNA Modifications In LNP Formulations With MMS")
Understand how Microfluidic Modulation Spectroscopy (MMS) provides early insights into RNA degradation within LNP formulations, offering a label-free approach to monitoring chemical integrity.
