From research to clinical manufacturing.
Designed to enable small scale to commercial scale manufacturing of liposomal drug products.
LIPEX® extruders generate homogeneous populations of unilamellar vesicles (liposomes) without need for solvents or detergents. A simple, one-step procedure extrusion produces liposomes by forcing aqueous suspensions of lipid through polycarbonate filters with defined pore size.
This relatively gentle process exposes formulations to moderate pressures of 100-700 psi at controlled temperatures, contrasting with homogenization where temperatures fluctuate and pressures often exceed 18,000 psi.
As the industry standard, this 10 mL small-scale unit was supplemented with 100 and 800 mL units to facilitate scale-up and GMP production of early-stage clinical products. Later, 142 and 293 mm stand-alone filter holders were introduced to support large-scale batch preparation under cGMP.
LIPEX® extruders offer advantages over alternative lipid manufacturing strategies:
Homogeneous vesicle size
High trapping efficiency
Can be used with a wide variety of lipid compositions
Built from durable, high quality 316 L stainless steel
Scalable from 1.5 mL at the lab bench to hundreds of liters at commercial production
Commercial scale systems designed to meet GMP and cleanroom requirements
LIPEX® technology is the equipment of choice for seamless scale-up from research to clinical manufacturing.