Manufacturing and Bioprocessing
2019 PharmSci 360
Nanoparticles are an effective, non-viral means to deliver genetic and small molecule payloads. The preparation of nanoparticles using microfluidic mixing has been widely used as a dependable and predictable research tool for developing a wide range of novel formulations for a broad spectrum of applications. To date, this work has been performed on previously published microfluidic structures such as flow-focusing and staggered herringbone mixers. We have developed a novel, next-generation microfluidic structure (NxGen) that overcomes the challenges of scaling up complex nanoparticle formulations. Specifically, NxGen mixers preserve time-invariant mixing conditions over a wide range of flow rates (0.2 to 20 L/h) using a single mixing element, thus enabling the predictable development of many classes of nanoparticles including liposomes, PLGA nanoparticles and nucleic acid encapsulating lipid nanoparticles. This high-capacity NxGen mixer has been integrated with a GMP system to manufacture large-scale nanoparticle batches for IND enabling studies and clinical trials.