Improved Liposome Manufacturing Process

由于稳定性、无菌性和成本的限制，需要大规模的脂质体制造工艺来满足日益增长的市场对脂质体药物递送和控释载体的需求。Bio-Eng正在开发一种大规模的脂质体制造工艺，该工艺有可能改善脂质体的特性和封装效率，同时满足生物技术和制药行业的市场需求。在Bio-Eng临界流体脂质体（CFL）制造过程中，用于制备脂质体的有机溶剂被临界流体溶剂取代，由于减压力，临界流体溶剂可以作为均质剂。在脂质体制造过程中，用关键流体溶剂取代有机溶剂将减少磷脂和封装疗法的降解，并允许快速溶剂分离、回收和再利用。与现有的实验室和商业脂质体制备工艺相比，所提出的工艺有几个潜在的好处。预期的好处是：不使用有机溶剂；所制脂质体的终端灭菌；无氧大气；与高压均质相比，压力要求更低；降低运营和制造成本；更高的处理速度；形成均匀冷冻和解冻临界流体脂质体的可能性；连续操作的能力；和 可伸缩性。

There exists a need for large scale liposome manufacturing processes which can meet the growing market demand for liposomal drug delivery and controlled release vehicles with the constraints of stability, sterility, and cost. Bio-Eng is developing a large-scale liposome manufacturing process which has the potential to improve liposome characteristics and encapsulation efficiencies while meeting the market needs of the biotechnology and pharmaceutical industries. In the Bio-Eng critical fluid liposome (CFL) manufacturing process, organic solvents used in the preparation of liposomes are replaced with critical fluid solvents which, as a result of decompressive forces, can act as a homogenizing agent. The displacement of organic solvents with critical fluid solvents in the liposome manufacturing process will reduce the degradation of phospholipids and encapsulated therapeutics, and allow rapid solvent separation, recovery, and reuse. There are several potential benefits to the proposed processes over existing laboratory and commercial processes for the preparation of liposomes. The anticipated benefits are: non-use of organic solvents; terminal sterilization of the manufactured liposomes; an oxygen free atmosphere; lower pressure requirements when compared to high pressure homogenation; lower operating and manufacturing costs; higher speed of processing; the potential formation of uniform frozen and thawed critical fluid liposomes; the ability to operate continuously; and scalability.