Improved Liposome Manufacturing Process

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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.