End-To-End Manufacturing Process for Improved Recovery and Integrity, Combined With Innovative Analytics of LNP-Based Biopharmaceuticals

Join this interactive workshop with hands-on demonstrations to learn and discuss the manufacturing of LNP-based biopharmaceuticals. Manufacturing challenges include ensuring drug product integrity, achieving high recovery rates, and obtaining well-characterized products. The process starts with plasmid DNA (pDNA), utilizing the Alkalizator system for GMP-compliant processing. Chromatographic purification with monoliths produces pure linear pDNA, which is transcribed into mRNA in the IVT reaction. This is followed by targeted capture and polishing using a flexible monolith toolbox for various RNA formats. After the purified RNA is encapsulated into LNPs, a novel purification method for LNPs is introduced, replacing TFF and dialysis. Utilising the CIMmultus OH monolithic column, recovery rates, particle size distribution, and bioactivity are enhanced. The PATfix platform monitors product quality, with the PATfix LNP Switcher characterizing multi-cargo LNPs for CAR-T, CRISPR, and vaccine formulations. This end-to-end platform using monoliths showcases process intensification, chromatographic innovation, and integrated analytics, advancing scalable, high-purity RNA-LNP therapeutics for next-generation biopharmaceuticals.