ABSTRACT
The commercial realization of the therapeutic potential of liposomal drugs rests, in part, on the ability to produce batches in a commercial setting that have reproducibly the same quality attributes as those used during nonclinical and clinical development. Part of this is obviously related to formulationboth composition and the basic manner in which drug containing liposomes are produced-and literature discussing liposomal drugs is naturally dominated by these aspects. The purpose of this chapter is to contrast the role of the details of process parameters and technology, raw material quality, and quality control testing, versus a simple focus on formulation. Examples given below highlight the fact that differences in the process of manufacturing liposomes can, in many cases, be of equal importance.
