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By AR Welch, Editorial & Community Director, Advancing RNA | Here, I wanted to share a few additional details from Parrella’s presentation about the efforts he and his team at Kernal Biologics made to improve their overall mRNA-LNP COGS. Though he emphasized the amount of opportunity that exists to improve our utilization of costly raw materials/reagents, as he revealed, there are also opportunities for process simplification. | |
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While the promise of diversifying RNA delivery methods is clear, real-world barriers remain. Here, panelists identify several of the biggest hurdles to adoption for their LNP alternatives, including the complexity of scaling cell-based manufacturing to GMP standards, misconceptions, limited clinical precedent, and regulatory uncertainty. |
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| Navigating The Regulatory Landscape For mRNA-Based Therapeutics | Article | Roche CustomBiotech | While organizations adapt to evolving safety and efficacy standards for mRNA, collaboration remains essential for navigating challenges like differing regional requirements, higher dosing needs, and analytical complexities. |
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| Development And Optimization Of LNP Formulations | Application Note | KNAUER | 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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