Size reduction, purification, sterilization and storage/packaging of liposomes

摘要: Despite the ever-growing number of positive laboratory results and the anticipated doubling of the global liposome-based drug market in the next 10 years, liposomes have not progressed to the clinic as quickly as expected. A major challenge in the clinical translation of liposomes is that the scale-up of the multistep manufacturing processes required to make these complex formulations requires highly specialized equipment, extensive optimization, and several regulatory considerations. This chapter focuses on the major manufacturing steps needed after liposome formation—namely, size reduction, purification, sterilization, and storage/packaging. Why and how these steps are needed is discussed in terms of industrial relevance as well as regulatory compliance.