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| Join Advancing RNA Live for a deep dive into mRNA-LNP development, tackling key CQAs, manufacturing challenges, and the need for innovation in analytics, PAT, automation, and more. Explore strategies to enhance quality at smaller scales and navigate the future of advanced manufacturing. Reserve your spot for this free digital event happening March 13th! |
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By AR Welch, Editorial & Community Director, Advancing RNA | Overall, I felt that the following initiatives/talking points were demonstrative of the types of creativity and symbiosis that we will need much more of in the near and long-term to foster a healthy and fruitful RNA ecosystem. | |
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By Kim Benton, Dark Horse Consulting | The FDA released final guidance on the Advanced Manufacturing Technologies Designation Program at the end of December. This article shares a summary, analysis, and how it compares to the 2023 draft. | |
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In this segment, Replicate Biosciences’ Andy Geall, Qian Ruan, & Alex Aust identify the most promising technological and raw material innovations that are influencing the drug substance and drug product production processes at CDMOs. |
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| Alternatives To CRISPR-Cas9: Nucleases For Next-Gen Therapy | Application Note | By Rebecca Roberts, Ph.D., Synthego Corporation | Alternatives to CRISPR-Cas9 address limitations like delivery challenges and off-target effects. Emerging nucleases offer improved specificity, smaller sizes, and therapeutic applications. |
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| Improving Toxicology Testing For Inhalation Products | Article | Battelle | By embracing new approach methods, regulatory agencies can revolutionize toxicology testing. These methods can be adapted for various medications, including inhalers and nasal-administered drugs. |
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| Lessons In Scaling Lipids Production And Purification | Article | Curia | The speed at which mRNA drug products are developed and manufactured at large scale is astounding, yet it has highlighted supply chain vulnerabilities for required pharmaceutical ingredients such as lipids. |
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