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
The clinical promise of mRNA therapeutics and vaccines is clear, but compared to monoclonal antibodies or viral vectors, their novelty also brings new challenges to the manufacturing process.
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.
Explore how lipid nanoparticles are revolutionizing non-viral gene editing with scalable, efficient delivery for both ex vivo and in vivo applications, which features new CRISPR-LNP data in T cells.
Overcome LNP upscaling challenges by leveraging fluid mechanical principles. Learn how Impingement Jets Mixing achieves reproducible turbulence and consistent LNP quality across all production scales.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1437856375-lnp-lipid-nanoparticle]( "Regulatory Considerations For Excipients Used In Lipid Nanoparticles")
Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
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![Lipid Nanoparticles GettyImages-1437855772]( "Rethink Cell Therapy With LNPs")
Explore how lipid nanoparticles are revolutionizing cell therapy workflows to enable the precise delivery of mRNA and gene editing tools for next-generation treatments like CAR T and HSC therapies.
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![GettyImages-1307980860-dna-rna-vial-gene]( "Optimizing Lipid Formulations For Targeted RNA-LNP Applications")
Learn about the considerations and challenges of using ionizable lipids, including the 5 types of lipids used for RNA delivery.
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![RNA abbreviation of ribonucleic acid-GettyImages-1453953422]( "Navigating Challenges In Progressing Breakthrough RNA Therapeutics")
RNA therapeutics hold immense promise for precision treatment, but their development faces challenges. A CDMO with adaptable platforms and flexible timelines can help reduce time and costs.
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![GettyImages-970394878-genetic-engineering-gene-editing-dna]( "Genome Editing Using mRNA-Lipid Nanoparticles For CAR T Cell Therapy")
Gene delivery platforms must support a diversity of genetic engineering strategies for genomic medicine development. Learn how lipid nanoparticles can accelerate development from discovery to scale-up.
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![GettyImages-1087219020 Scientists wearing protective coveralls working in manufacturing laboratory]( "Insights Into GMP Manufacturing Of RNA-LNP Drug Products")
Explore key considerations for manufacturing RNA-LNP drug products surrounding process and analytical development, automation, environmental monitoring, and strategic collaborations.
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![iStock-1295693740-covid-coronavirus-vaccine-mrna]( "Developing A Scalable RNA-LNP Drug Product For Clinical Translation")
Accelerate essential process development activities with instrumentation solution allowing for highly reproducible and scalable production of RNA-LNPs.
