加拿大 LIPEX Biomembranes 挤出压机

LIPEX Biomembranes于1985年引入，LIPEX?挤出压机是制备实验室级脂质体制剂的行业标准。这10毫升的小型单位补充了100和800毫升单位，以促进放大和早期临床产品的GMP生产。后来又引进了142和293毫米的独立式过滤器支架，以支持cGMP下的大规模批量制备，同时使用氮气压力和制药级泵。

加拿大LIPEX?挤出压机生成均匀的单层囊泡（脂质体）群体，而不需要溶剂或洗涤剂。一个简单的一步程序，挤出生产脂质体的脂质水悬浮液通过聚碳酸酯过滤器具有确定的孔径。这种相对温和的方法使得配方在控制温度下达到100-700psi的中等压力，与温度波动和压力经常**过18,000psi的均化相反。

加拿大LIPEX挤出压机提供优于替代脂质生产策略的优势：

由高级不锈钢制成，没有移动部件
*控制的均匀粒度
可实现高捕获效率
各种各样的脂质组合物
没有产品量的限制。
运营成本低
易于使用的设备
LIPEX?技术是从研究到临床制造无缝放大的可以选择设备。
 
Introduced by LIPEX? Biomembranes in 1985, the LIPEX? Extruder is the industry standard for the preparation of laboratory-scale liposome formulations. 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, using both nitrogen pressure and pharmaceutical-grade pumps.

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.

LIPEX Extruders offer advantages over alternative lipid manufacturing strategies:

manufactured from high grade stainless steel with no moving parts
readily controlled homogeneous particle size
achievable high trapping efficiencies
wide variety of lipid compositions
no product volume restrictions.
low operating costs
easy-to-use equipment
LIPEX? technology is the equipment of choice for seamless scale-up from research to clinical manufacturing.