Meeting regulatory needs in the characterization of lipid nanoparticles (LNPs) for RNA delivery via FFF-MALS

Abstract

Field-flow fractionation coupled to multi-angle light scattering (FFF-MALS) is a powerful analytical approach for the advanced characterization of nanomaterials (sizes < 1 μm). Contrary to size-exclusion chromatography, no stationary phase is required during the fractionation process, and the optimal separation range can be fine-tuned to measurement parameters. This flexibility enables reliable measurement of complex pharmaceutical products such as nanomedicines, monoclonal antibodies and vaccines. However, for quality control purposes the FFF-MALS protocol must satisfy regulatory needs and accepted standards. Here, we describe a validated FFF-MALS method in line with technical specification ISO/TS 21362 for the analysis of lipid-based nanoparticles (LNPs) encapsulating siRNA and mRNA.