Characterizing LNPs: Meeting Regulatory Expectations With FFF-MALS

This executive summary examines how field-flow fractionation coupled with multi-angle light scattering (FFF-MALS) characterizes lipid nanoparticles (LNPs) as regulatory expectations from FDA, EMA, and USP converge on a shared set of critical quality attributes. It walks through how FFF-MALS resolves particle size, molar mass, and payload distribution in a single non-destructive run, and includes a case study comparing two authorized mRNA vaccines. Readers will see how size-resolved analysis uncovered differences in payload distribution that bulk-average methods missed.