Evonik’s recently launched LIPEX® Flow extruder builds on a platform of liposome extruders that 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 achieve a specified vesicle size in a reproducible and scalable process. 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, a homogenous population, and high yield. To provide an integrated scale-up process from drug discovery through to GMP production, a range of our products are available from Evonik at the lab, pilot, intermediate and commercial-scale.
LIPEX® FLOW: CONTINUALLY BUILDING ON A PROVEN, ROBUST AND HIGHLY SCALABLE DESIGN FOR HIGHER THROUGHPUT AND FASTER BATCH PROCESSING TIMES
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 heterogenous population of multi-lamellar vesicles. The unilamellar vesicles are formed by applying a pressure of between 100 and 2400psi to force the vesicles through polycarbonate filters of a defined pore size.
The newly designed LIPEX® Flow incorporates a novel drain cavity which increases the throughput capacity without affecting the ability to reduce particle size. More than a fifty percent reduction in extrusion pressure ensures higher flow rates at lower pressures. Additionally, the new design has increased the operating pressures up to 2450psi (170 bar). Together, this allows you to extrude more material with reduced filter clogging and less frequent filter changes. This leads to faster batch processing times while still ensuring quality spherical particles. The new model further minimizes process risks by reducing the need to open extruders which can lead to contamination or safety issues, for example when handling HPAPIs. Target formulations that are difficult to extrude such as hydrophobics, or concentrated lipid suspensions can benefit from the higher operating pressure.
LIPOSOME EXTRUDERS AVAILABLE IN A RANGE OF SIZES TO SUPPORT ANY BATCH VOLUME REQUIREMENT
LIPEX® liposome extruders can support production volumes from 1mL 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 10 mL benchtop units to support your small-scale batch requirements.
For early-stage clinical trials, our 100 mL and 1000 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 integrated into turnkey, automated skid systems, which employ both nitrogen pressure and pharmaceutical-grade pumps.
We can supply you with your own purpose-built equipment in these standard sizes and are also able to create customized products that are tailored to meet your process requirements.
Looking for more information on LIPEX® Flow?
Download our brochure to learn more about our LIPEX® Flow thermobarrel extruder packages.
OTHER MANUFACTURING TECHNOLOGIES FOR RAPID, REPRODUCIBLE AND SCALABLE LIPID MANUFACTURING
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 1 mL and dozens of liters.