Liposomes are well recognised as effective drug delivery systems, with a range of products approved, including follow on generic products. Current manufacturing processes used to produce liposomes are generally complex multi-batch processes. Furthermore, liposome preparation processes adopted in the laboratory setting do not offer easy translation to large scale production, which may delay the development and adoption of new liposomal systems. To promote advancement and innovation in liposome manufacturing processes, this review considers the range of manufacturing processes available for liposomes, from laboratory scale and scale up, through to large-scale manufacture and evaluates their advantages and limitations. The regulatory considerations associated with the manufacture of liposomes is also discussed. New innovations that support leaner scalable technologies for liposome fabrication are outlined including self-assembling liposome systems and microfluidic production. The critical process attributes that impact on the liposome product attributes are outlined to support potential wider adoption of these innovations.
Keywords: Cationic liposomes; Leciplex; Lipid nanoparticulate; Liposomes; Microfluidics; Monoclonal antibody; Nanomedicine; Oligonucleotide; Phospholipids; Targeted delivery.
Copyright © 2020. Published by Elsevier B.V.