MANUFACTURING ARTICLES
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The Future Of RNA Manufacturing: Continuous Processing, AI, And Distributed Production (Pt. 3)
Continuous manufacturing, AI, modular facilities, and next-generation RNA platforms are reshaping how therapies are produced, scaled, and delivered worldwide.
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Can Oligonucleotide Regulations Keep Up With Manufacturing Innovation?
Here in part 2 of my TIDES takeaways, I’ll unpack which guidances we have at our disposal today in the oligo world, and what we can expect in the future.
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Unlocking The Future Of mRNA
Many regulatory frameworks and analytical approaches were not originally designed for platforms like mRNA. Addressing these gaps will be essential to fully realize the potential of mRNA technologies.
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The Hidden Bottleneck In Advanced Therapies Isn't Science… It's Translational Friction
Scientific breakthroughs may spark innovation, but operational excellence ultimately determines which advanced therapies reach patients.
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RNA Therapeutics: Why CMC Strategy Will Define The Next Decade
As 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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Rethinking The Oligonucleotide Backbone: Why RNA Therapeutics May Need A New Molecular Design Framework
New backbone chemistries could unlock greater control over delivery, specificity, and safety, expanding the molecular design space for RNA medicines.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Experts note CGT programs often struggle due to limited operational readiness; early standardization supports scalable, reproducible, regulatory‑ready development and helps prevent late‑stage bottlenecks.
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We show CRISPR/Cas9-mediated knockouts of the T cell receptor and explore multi-step LNP engineering to produce TCRɑβ KO CAR T cells, a promising approach towards allogeneic CAR T cell therapy.
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Optimizing pDNA production in E. coli requires strategic media selection and scale-up planning. Explore a study that identifies ideal conditions for high-yield manufacturing.
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Achieve high-resolution separation of circular RNA (circRNA) species from linear RNA products, and detect impurities present at 0.1% of that main product, using an mRNA analysis kit.
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The production of lipid nanoparticles (LNPs) is a process that demands robustness, scalability, and reproducibility. Examine the impact of key operational parameters on the efficacy of LNPs.
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Learn about the key stages of drug discovery and screening as well as how to overcome bottlenecks in screening mRNA-LNPs to rapidly develop genomic medicines.
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Overcoming the challenges of manufacturing and administering a complex product to any patient is critical for delivering cell therapies. Two industry experts detail strategies to meet supply chain challenges.