This poster presents a comprehensive approach to optimizing the mRNA-LNP production process, focusing on key steps from plasmid DNA expression in E. coli to encapsulating nucleic acids into lipid nanoparticles for effective delivery. It outlines challenges in manufacturing and characterization, emphasizing the importance of maintaining product integrity and recovery during purification.
CIM monolithic columns, utilized in this study, are integral to refining separation processes, offering high-resolution purification and enhancing product quality by efficiently removing impurities and ensuring consistent performance. The PATfix system provides real-time analytics, monitoring quality attributes throughout the process, while the PATfix LNP Switcher Platform assesses encapsulation efficiency, RNA quantity, and purity, ensuring high-quality LNP formulations.
This study demonstrates the effectiveness of advanced bioprocessing strategies and analytical tools in improving the quality and scalability of RNA-LNP-based therapies, offering promising solutions for multi-nucleic acid delivery.
