Emulsification process for preparing multivesicular liposomes

Multivesicular liposomes are prepared on a commercial scale by combining a first water-in-oil (w/o) emulsion with a second aqueous solution to form a water-in-oil-in-water (w/o/w) emulsion using a static mixer. The solvent is removed from the resulting emulsion to form multivesicular liposome-containing compositions. Further optional process steps include primary filtration and secondary cross-flow filtration. The products produced according to the processes described can be produced through a series of aseptic steps. The process for preparing a multivesicular liposomal particle composition comprises: a) providing a volume of first emulsion by mixing a volume of a first aqueous phase and a volume of a volatile water-immiscible solvent phase, said solvent phase comprising at least one amphipathic lipid and at least one neutral lipid; b) mixing and emulsifying the first emulsion and a volume of a second aqueous phase in a mixer to provide a volume of a second emulsion, the second emulsion comprising a continuous aqueous phase; and c) removing the volatile water-immiscible solvent from the second emulsion to form a volume of multivesicular liposomal particle composition, wherein all steps are carried out under aseptic conditions, and wherein all solutions are sterile filtered, and wherein the multivesicular liposomal particle composition is immediately suitable for administration into humans.