PDF《Polymun Scientific》

18550201458 Polymun has transformed liposomes from a promising scientific idea into a sound industrial solution. The production technology is suitable for a broad range of substances formulated by passive entrapment, active loading or membrane incorporation. Polymun Technology Main characteristics of our technology Full Scalability The injection module is the heart of the liposome production. The?process parameters determine the size of the liposomes regardless of the scale. Production of

250 liters of liposome preparation takes only 1.5?hour. Large scale also can be achieved by using several injection?modules in parallel. Aseptic Process A closed system is used for production. All components can?be added via sterile filtration. Subsequent concentration?by?crossflow filtration is possible as well. Homogeneous, Uniform Vesicles All process parameters are controlled precisely. This?results in?a very narrow size distribution, necessary for?reliable targeting and transport characteristics. Single Step Process Liposome size is adjusted by modulating the process parameters during vesicle formation. No additional downsizing?is required. Excellent Batch to Batch Consistency High quality of raw materials and precisely controlled process parameters guarantee excellent reproducibility C essential for pharmaceutical products. Mild Procedure C Stability The crossflow injection technique is a very mild procedure?that allows the processing of sensitive drugs. Together with the high quality of raw materials and narrow size distribution, we achieve long term stability of?liposomes?even at room temperature. Homogeneous, Uniform Vesicles cGMP Production Patents Method and device for producing lipid vesicles granted by: AU 2002215987;

CA 2,427,640;

EP 1337322;

US 6,843,942 Application of superoxide dismutase in liposomes granted by: AU 690377;

CA 2,204,493;

EP 0789584;

MX 206295;

NZ 296098;

US 5,942,245;

US 6,312,720 Superloaded liposomes for drug delivery granted by: EA 200602172;

CN 1960706A;

pending in: AU, CA, EP, IN, JP, KR, US, international?stage WO2005115337 Liposomal composition comprising an active ingredient for relaxing smooth muscle production and therapeutically use of said composition granted by: AU 04024753.8;

EA 011391;

EP 1802277;

NZ 554183;

pending in: CA, CN, IN, JP, KR, US, international stage WO2006042701 selected Publications Wagner A, Vorauer-Uhl K (2011) Liposome Technology for Industrial Purposes. Journal of Drug Delivery 2011, 9?pages Wagner A, Stiegler G, Vorauer-Uhl K, Katinger H, Quendler H, Hinz A, Weissenhorn W (2007) One Step Membrane Incorporation of Viral Antigens as a Vaccine Candidate Against HIV. J Liposome Res 17(3):139-54 Wagner A, Platzgummer M, Kreismayr G, Quendler H, Stiegler G, Ferko B, Vecera G, Vorauer-Uhl K, Katinger H (2006) GMP Production of Liposomes-A New Industrial Approach. J Liposome Res 16(3):311-9 Vorauer-Uhl K, Wagner A, Borth N, Katinger H (2002) Long term stability of rh-Cu/Zn-SOD-liposomes prepared by the crossflow injection technique following ICH-guidelines. European Journal of Pharmaceutics and Biopharmaceutics 54:77-81 Wagner A, Vorauer-Uhl K, Kreismayr G, Katinger H (2002) Enhanced protein loading ........