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| Addressing the most prominent pain points of speed, cost of production and limited flexibility, the mRNA Process Development & Manufacturing Summit returns to Boston this September. Hear from 30+ technical experts from the likes of Moderna, BioNTech, Sanofi and Strand Therapeutics across three days of content spanning tracks dedicated to Research Scale and IND-Enabling & Clinical Scale production. See program here. |
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By AR Welch, Editorial & Community Director, Advancing RNA | mRNA’s small-scale and cell-free production are often-touted benefits in the personalized medicines sphere. But as I reviewed my notes from the BioPhorum ATMP member event, I found myself coming face to face with a difficult truth. |
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By Blake Bergam and Sara Mills, Dark Horse Consulting Group | FDA has released the new draft guidance for industry, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products. This article provides a summary — and shares what is shocking about the guidance. |
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Experts from this Advancing RNA Live panel discuss the results from a poll question revealing the top three areas RNA industry experts would be most interested in seeing additional mRNA-specific guidance from regulatory agencies. |
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| Mechanisms Of LNP-Mediated mRNA Delivery | Article | By Michael Nguyen, Ph.D., Helix Biotech | Explore the details supporting LNP-mediated mRNA delivery, as well as the challenges facing mRNA based therapeutics in the future. |
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