RenowneduserapplicationApplikon’sBioSepsystemContentOverviewPrincipleofoperationBioSepPublicationresultsCustomersinEuropeNovartis,Cell,cGMPDutchVaccineInstitute,Cell,cGMPHPA,UK,Cell,cGMPGlaxoSmithKline,Cell,cGMPBoehringerIngelheim,Cell,cGMPSolvayPharmaceuticals,Cell,cGMPAstraZenecaBayer,Cell,cGMPEliLillyPfizerFraunhoferInstitute,cGMPDiosynth,Cell,cGMPPharmaciaAvantisPasteur,Cell,cGMPMerial,Cell,cGMPAlbaBiosciences,Cell,cGMPSanofiAventisSandozVivalis,Cell,cGMPAvecia,Cell,cGMPL.F.B.,Cell,cGMPCobraBiologicals,Cell,cGMPCentocor,Cell,cGMPSerbio,Cell,cGMPNatl.BioManuf.Centre,Cell,cGMPOctoPlusU.C.B.Celltech,Cell,cGMPCancerResearch,Cell,cGMPSyncoBioPartners,Cell,cGMPCustomersinUSABayer,Cell,cGMPGenentech,Cell,cGMPBristolMyersSquib(BMS)Zymogenetics,Cell,cGMPWyethPharmaceuticalsBioMarine,Cell,cGMPInvitrogenAmgen,Cell,cGMPBiogenIDEC,Cell,cGMPAbbottGlaxoSmithKline(GSK),Cell,cGMPMerck,Cell,cGMPCubist,CgmpSigmaAldrich,Cell,cGMPMedimmune,Cell,cGMPImclone,Cell,cGMPCambrex,Cell,cGMPCookPhamica.OverviewManycompaniesworkwithApplikonMicroscaleuptoPilot/ProductionscaleBioSepisuniqueproductforperfusionRenoweduserapplicationBioSepintegrationPrincipleofoperationHighmovement/LowpressureplaneLowmovement/HighpressureplaneCellsaccumulateinlowpressureplanesHighmovement/LowpressureplaneAcousticstandingwaveClarifiedharvestConcentratedcellsuspensionCell“banding”CellsedimentationDetailcellbandBioSep:EconomicalImpact-Perfusionvs.BatchViablecellconcentration:Factor10-20Antibodyconc.inharvest:Factor2-5Antibodyproduction/reactorvolume/day:Factor10-100=>smallerreactorScalable1L–1000LcGMPBioSep1000LBioSepchamber1000LScalable1L–1000LcGMPBioSep10LScalable1L–1000LcGMPBioSep50LScalable1L–1000LcGMPBioSep200LSetupBioSepAutoclavablechambersPlaceddirectonbioreactorforlabandpilotscale:BioSep10LBioSep50LSetupBioSep200LBioSeptechnologyproventechnology,>400systemssoldAppliedincGMPconditionCosteffectivePublicationsCNRC,CanadaDSMBiologics,NetherlandsUBC,CND/Zymogenetics,USA*HumanGenomeSciences,USAGenentech,USASerono,SwitserlandSetupBioSep200L130LBioreactorwithBioSep200L(inGMPfacility)Gorenfloetal,2002Gorenfloetal,2002Gorenfloetal,2002-ConclusionsScalablefrom10L/dayto200L/dayEfficiency>95%up1*107cell/mlSimpleandreliableQuestions?
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