生物反应器课件 Renowed customer application Applikon’s BioSep system.ppt

Renowned user application Applikons BioSep system Content Overview Principle of operation BioSep Publication results Customers in Europe Novartis, Cell, cGMPDutch Vaccine Institute, Cell, cGMP HPA, UK, Cell, cGMPGlaxo Smith Kline, Cell, cGMP Boehringer Ingelheim, Cell, cGMPSolvay Pharmaceuticals, Cell, cGMP Astra ZenecaBayer, Cell, cGMP Eli LillyPfizer Fraunhofer Institute, cGMPDiosynth, Cell, cGMP PharmaciaAvantis Pasteur, Cell, cGMP Merial, Cell, cGMPAlba Biosciences, Cell, cGMP Sanofi AventisSandoz Vivalis, Cell, cGMPAvecia, Cell, cGMP L.F.B., Cell, cGMPCobra Biologicals, Cell, cGMP Centocor, Cell, cGMPSerbio, Cell, cGMP Natl. BioManuf. Centre, Cell, cGMPOctoPlus U.C.B. Celltech, Cell, cGMPCancer Research, Cell, cGMP Synco BioPartners, Cell, cGMP Customers in USA Bayer, Cell, cGMP Genentech, Cell, cGMP Bristol Myers Squib (BMS)Zymogenetics, Cell, cGMP Wyeth PharmaceuticalsBioMarine, Cell, cGMP InvitrogenAmgen, Cell, cGMP Biogen IDEC, Cell, cGMPAbbott Glaxo Smith Kline (GSK), Cell, cGMPMerck, Cell, cGMP Cubist, CgmpSigma Aldrich, Cell, cGMP Medimmune, Cell, cGMPImclone, Cell, cGMP Cambrex, Cell, cGMPCook Phamica. Overview Many companies work with Applikon Micro scale up to Pilot/Production scale BioSep is unique product for perfusion Renowed user application BioSep integration Principle of operation High movement / Low pressure plane Low movement / High pressure plane Cells accumulate in low pressure planes High movement / Low pressure plane Acoustic standing wave Clarified harvest Concentrated cell suspension Cell “banding” Cell sedimentation Detail cell band BioSep: Economical Impact - Perfusion vs. Batch Viable cell concentration:Factor 10-20 Antibody conc. in harvest:Factor 2-5 Antibody production /reactor volume/day: Factor 10-100= smaller reactor Scalable 1L 1000L cGMP BioSep 1000 L BioSep chamber 1000L Scalable 1L 1000L cGMP BioSep 10L Scalable 1L 1000L cGMP BioSep 50L Scalable 1L 1000L cGMP BioSep 200L Setup BioSep Autoclavable chambers Placed direct on bioreactor for lab and pilot scale: BioSep 10L BioSep 50L Setup BioSep 200 L BioSep technology proven technology, 400 systems sold Applied in cGMP condition Cost effective Publications CNRC, Canada DSM Biologics, Netherlands UBC, CND / Zymogenetics, USA * Human Genome Sciences, USA Genentech, USA Serono, Switserland Setup BioSep 200 L 130L Bioreactor with BioSep 200L (in GMP facility) Gorenflo et al, 2002 Gorenflo et al, 2002 Gore