Sterilizing-Grade Filtration Of mRNA Encapsulated Lipid-Nanoparticles

Sterilizing-grade filtration must deliver reliable microbial retention without altering the critical quality attributes of mRNA-LNP formulations. Constant-pressure VMAX testing compared the throughput and flux of several Cytiva and competitor PES membrane filters at 40 and 10 psig under representative process conditions. Supor™ Prime achieved the highest throughput and flux at both pressures, while Supor™ EX ECV and Fluorodyne™ EX EDF provided equivalent or better performance than the competitor membranes tested. Supor™ Prime and Fluorodyne™ EX EDF also removed all incident Brevundimonas diminuta bacteria at both high and low test pressures. Analysis confirmed that filtration did not adversely affect mean particle diameter, polydispersity index, or encapsulation efficiency for capped and uncapped mRNA-LNP formulations.

Watch the full webinar to compare filter performance and inform sterilizing-grade filtration decisions for mRNA-LNP processing.