FORMULATION ARTICLES
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![cancer cell screening, disease treatment medical-GettyImages-2189938556]( "Powering Cell Therapies With RNA: A New Code For Engineered Immunity")
Powering Cell Therapies With RNA: A New Code For Engineered ImmunityRNA is redefining cell therapy engineering—enabling transient, programmable control of immune and stem cells while simplifying manufacturing, improving safety, and accelerating scalable, virus-free workflows.
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![digital exchange, money transfer-GettyImages-2148127398]( "Why RNA Tech Transfer Is So Hard — And How the Field Can Fix It")
Why RNA Tech Transfer Is So Hard — And How the Field Can Fix ItA closer look at why RNA tech transfer remains one of the field’s toughest bottlenecks — and the practical steps developers and CDMOs can take to finally streamline the path to GMP.
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![GettyImages-1128195910-vial-white-powder-lyophilization]( "Four Reasons You Should Choose Lyophilization for Your Next Project")
Four Reasons You Should Choose Lyophilization for Your Next ProjectLyophilization ensures product stability, extends shelf life, supports sensitive formulations, and simplifies storage and transport, making it a critical choice for modern drug development projects.
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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.
FORMULATION VIDEOS
Together, Life Edit Therapeutics’ April Sena and Sanofi’s Troiano share their perspectives on raw material quality & IP-related considerations for managing the supply chain for next-generation RNA modalities.
Review strategies to assess the potential for human immune response following the administration of an mRNA therapeutic, the associated LNP, and the protein encoded for by the mRNA.
Discover how revolutionary and environmentally sustainable nanoparticle technologies coupled with innovative formulation approaches can address drug solubility issues and add value for patients.
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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1437856375-lnp-lipid-nanoparticle]( "Harnessing Chemistry For Scalable Manufacture Of Lipids Used In mRNA Delivery")
Discover how scalable lipid nanoparticle (LNP) technology is revolutionizing mRNA-based therapies and shaping the future of treatment innovation.
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![Lipid nanoparticle mRNA vaccine-GettyImages-1418152448]( "Development Of LNP Formulations Using The KNAUER NanoScaler")
Lipid nanoparticles (LNPs) offer a robust solution for nucleic acids. The NanoScaler system optimizes this technology, enabling scalable and reproducible LNP formulations for diverse applications.
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![GettyImages-950086574 drug development]( "Recommendations For Successful IND Approval Of RNA-LNP Drugs")
The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.
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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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![Covid Vaccine Production Line GettyImages-1336518535]( "Analytics And Bioassays Can Safely Fast-Track mRNA-LNP Drug Development")
One main mRNA technology challenge is the formulation of delivery systems like lipid nanoparticles (LNPs). Learn about evading impurities in lipids, the future of mRNA-based genomic medicines, and more.
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![mRNA GettyImages-1428646288]( "Establishing Analytical Methods For mRNA-Based Therapies")
Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
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![GettyImages-1311518492-vaccine-vial]( "Expanding Into New Fields Of “Cell-Grow-Culture” For mRNA Transfection")
Learn about one path forward to navigate the pitfalls with mRNA transfection and a medium to assist in lentivirus-mediated transduction of human mesenchymal stromal/stem cells (hMSCs).
