In liposome and lipid nanoparticle (LNP) drug-delivery applications, particle size is a critical quality attribute (CQA) that impacts bioaccessibility, retention time and biodistribution. Microfluidization is a common method for largescale production of liposomes within a well-defined size range. The resulting particle size is dependent on a number of process parameters, such as chamber pressure and temperature, which can drift over the course of time.
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.
