AN8006: In-line monitoring of liposome size by RT-MALS

In liposome and lipid nanoparticle (LNP) drug-delivery applications, particle size is a critical quality attribute (CQA) that impacts bioaccessibility, retention time and bio-distribution. Current on-line and off-line control methods do not sample the entire lot, and only provide average sizes, potentially hiding pockets of out-of-spec material. Real-time multi-angle light scattering (RT-MALS) ensures batch consistency by in-line monitoring for size of the entire batch; the collection stream can be diverted to waste if the particle size falls out of specification.