LIPEX® liposome extruders: equipment of choice for seamless scale-up from research to commercial manufacturing
Evonik’s platform of LIPEX® liposome extruders have set the industry standard for liposomal drug product manufacturing for almost 30 years. LIPEX® liposome extruders are widely used across the pharmaceutical and biotechnology industry to create homogeneous populations without the need for solvents or detergents. A one-step process forces aqueous suspensions of lipids through filters with a defined pore size. Unlike some alternative technologies, the relatively gentle pressures at controlled temperatures to which the formulations are exposed ensure optimal particle size reduction and high trapping efficiency. To provide an integrated scale-up process from drug discovery through to GMP production, a range of our products are available from Evonik in lab, pilot, intermediate and commercial-scale volumes. In addition to others, Evonik also offers a range of other technology solutions for liposome manufacturing including microfluidics.
Liposome extruders leveraging a proven, robust and highly scalable design for high-quality production
Our liposome extruders are manufactured using durable, high-quality 316 L stainless steel, have no moving parts, and require minimal maintenance to support the consistent, high-quality production of a range of lipid compositions at minimal operating costs. These are designed to produce a homogenous population of large unilamellar vesicles from a non-homogenous population of multi-lamellar vesicles. The unilamellar vesicles are formed by utilizing a constant pressure of between 100 and 800psi to force the vesicles through polycarbonate filters of a predefined pore size.
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Liposome extruders available in a range of sizes to support any batch volume requirement
LIPEX® liposome extruders can support production volumes from 1.5 mL at the laboratory benchtop to hundreds of liters at commercial-scale.
- During the initial R&D and pre-clinical periods to support formulation feasibility and development activities, we can supply 1.5 mL and 10 mL bench units to support your small-scale batch requirements.
- For early-stage clinical trials, our 100 mL and 800 mL units enable rapid scale-up.
- For large-scale GMP production to support late-stage clinical trials or commercial batch requirements, 142-mm and 293-mm stand-alone filter holders are available that employ both nitrogen pressure and pharmaceutical-grade pumps.
In addition to the supply of your own dedicated equipment in these standard sizes, we are also able to create customized products to address specific application or volume requirements.
Range of other manufacturing technologies for rapid, reproducible and scalable lipid manufacturing additional to liposome extruders
In addition to the development and supply of liposome extruders, Evonik also specializes in a range of other equipment utilized in the production of liposomes as well as polymeric microparticles, nanoparticles and implants. For example, we have extensive expertise in the use of microfluidics and micro mixing equipment to create homogeneous populations of liposomes via the controlled channeling of lipids dissolved in solvent and an aqueous buffer. This new, fast-growing process technology for liposome manufacturing is extrusion-free, and scalable from volumes between 1mL and dozens of liters.