FORMULATION ARTICLES
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![RNA molecule, Epigenetics-GettyImages-1914829121]( "Validation Of A RIG-I–Based Functional Assay For Quantitative Detection Of Double-Stranded RNA Impurities In mRNA Drug Substance")
Validation Of A RIG-I–Based Functional Assay For Quantitative Detection Of Double-Stranded RNA Impurities In mRNA Drug SubstanceA validated RIG-I assay adds a biology-informed layer to dsRNA testing by quantifying immunogenic impurities in IVT-derived mRNA therapeutics for deeper functional insight.
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![DNA abstract-GettyImages-2223439582]( "Suppressor tRNA Therapeutics: A New Frontier In Treating Genetic Disease")
Suppressor tRNA Therapeutics: A New Frontier In Treating Genetic DiseaseSuppressor tRNAs could unlock a scalable new way to treat genetic diseases caused by nonsense mutations, restoring full-length proteins across multiple indications.
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![Virus, microscopy, vaccine, covid-GettyImages-1439691672]( "Engineering Transient In Vivo CAR-T: Extending Expression, Expanding Access, And Rethinking Immune Reset")
Engineering Transient In Vivo CAR-T: Extending Expression, Expanding Access, And Rethinking Immune ResetIn this Q&A, Michael Lam, Ph.D., explores how circular RNA and targeted delivery extend transient CAR expression to enable deep B-cell depletion and controllable immune reset.
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![body immune response viral infection, Cancer Immunotherapy-GettyImages-2172360428]( "Engineering Repeat-Dose RNA: Engineering Around Immune Recognition In Repeat-Dose RNA Therapeutics")
Engineering Repeat-Dose RNA: Engineering Around Immune Recognition In Repeat-Dose RNA TherapeuticsDesigning repeat-dose RNA means engineering around immune recognition — optimizing payloads, purity, and delivery early to sustain efficacy, tolerability, and durability across multiple administrations.
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![DNA Helix, Futuristic Digital Interface, genetics, molecular biology, gene editing-GettyImages-2221747428]( "A Novel Co-Tethered Transcription Platform For High-Yield, High-Purity mRNA Synthesis")
A Novel Co-Tethered Transcription Platform For High-Yield, High-Purity mRNA SynthesisCo-tethered transcription boosts mRNA yield and purity by organizing transcription machinery, reducing dsRNA impurities, and streamlining production for scalable RNA therapeutics.
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![Drone Point View of Overpass and City Traffic at Night-GettyImages-1279832748]( "A New Approach To RNA Synthesis And Purification: Rethinking A Persistent Bottleneck")
A New Approach To RNA Synthesis And Purification: Rethinking A Persistent BottleneckPhotocleavable supports enable light-triggered RNA release, reducing reliance on chromatography and streamlining synthesis, scalability, and purity for complex RNA therapeutics.
FORMULATION VIDEOS
Gain valuable insights into key considerations when selecting lipid excipients for LNP formulations and the process development steps necessary to advance them to GMP manufacturing and clinical trials.
Discover cutting-edge equipment featuring high-pressure dosing technology that enables the efficient production of LNPs for diverse applications.
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 Advancing RNA Live clip, BioNTech’s Ben Muir and Hopewell Therapeutics’ Kate Zhang share their perspectives on the most exciting novel screening methods, innovative preclinical models, and next-gen technologies they hope can/will eventually help us bridge the translation gap between preclinical models and the clinic.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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.
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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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![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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![GettyImages-1392303980-chromatography-LC]( "Analysis Of LNP Lipids With Evaporative Light Scattering Detection")
Jump into this thorough analysis of lipids in LNP formulations using HPLC, a technique crucial for quality control in the production of mRNA vaccines and therapeutics.
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![mRNA GettyImages-1356994684]( "Levers To Optimize The IVT Reaction For Increased mRNA Yield")
Mastering IVT yield requires balancing magnesium and nucleotide ratios. Learn how specific buffers and pyrophosphatase optimize mRNA synthesis for scalable, high-quality therapeutic production.
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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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![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.
