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| When navigating the clinical trials process to bring a molecule to market, meeting the regulatory standards required for the approval of new mRNA-based drug products is critical. A crucial aspect is developing extensive chemistry, manufacturing, and controls (CMC) documentation, outlining the quality of drug substance and product. This article explores the regulatory requirements for mRNA drug substance and product, the importance of phase-appropriate quality, and insights on creating CMC documentation to ensure compliance. Download now! |
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By AR Welch, Editorial & Community Director, Advancing RNA | CureVac CEO Alexander Zehnder shares his thoughts/visions on how mRNA neoantigen vaccines could become even more revolutionary for patient populations in the future. Though it may be early days, this conversation is a great case study for how RNA companies are striving to keep both scientific and commercial market opportunities top of mind from the earliest days of development. | |
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By D. Barbara, The Alliance for mRNA Medicines; and J. Moss and L. Cao, Hanson Wade Intelligence | Recent advances in non-viral delivery technologies have enabled a first generation of genetically modified immune cells in vivo. Deploying these new approaches can address challenges with traditional ex vivo CAR-T cell therapy. | |
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Three LNP experts share their thoughts on the incremental advancements they’d like to see the RNA-LNP space make in the next few years. |
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