Abstract

Liposome-based complex injectables epitomize a rapidly expanding area in pharmaceutical research and development as they can enhance drug solubility, drug delivery and targeted efficacy, predominantly in oncology, infectious diseases, and vaccines. However, the transformation from laboratory-scale production to bulk manufacturing presents significant challenges due to the intricate attributes of liposomal formulation. This chapter presents a comprehensive analysis of the essential considerations in scaling up liposome-based injectables. The focus is on ensuring consistent product quality, effectiveness, and safety throughout every stage of the process. The impact of the critical components and characteristics of liposomes mainly their size, lamellarity, and surface charge, on the design and optimization of large-scale production processes have been discussed thoroughly. A plethora of production methods, like thin-film hydration, microfluidics, and extrusion, and all other complexities of scaling up these techniques require critical scrutiny for successful production at commercial scale. A deep understanding of upholding critical quality attributes of liposomes like particle uniformity, encapsulation efficiency, and sterility during large-scale manufacturing, as well as the role of advanced characterization techniques in ensuring quality control has been delibrated. Furthermore, the regulatory contemplations for scaling up liposome-based products, including the need for robust process validation and compliance with good manufacturing practices (GMPs), are addressed. This chapter concludes by delving into the future prospects in liposomal drug delivery, accentuating the advancements in manufacturing and automation that could facilitate the scale-up process. Moreover, it provides valuable perspectives on upcoming technologies that could streamline and improve large-scale production.