Cellufine产品介绍(XXXX)

CopyrightAllrightsreserved.11CHROMATOGRAPHYMEDIA(polysaccharide)Agarose(polysaccharide)SyntheticpolymerOriginPlantPlantChemicalsStructureCross-linkingagents(example)OOHOOHOOHO*OHO*OOHOHO*OOHOHO*OHOHOClOClOH2CH2COCC**CH3COHORawMaterialsParticlesBaseResinCrosslinkCellufineMediaPorosity,Particlesize,HardnessCellufineBaseResinCopyrightAllrightsreserved.444OHOH2COHOHOOOHOH2CHOOHOOHOH2COHOHOOOHOH2CHOOHOHOHO99RigidandstableRigidandstable99GoodbiocompatibilityGoodbiocompatibility99LowernonspecificadsorptionLowernonspecificadsorptionƒƒCellulosehasthesuperiorphysical/chemicalCellulosehasthesuperiorphysical/chemicalpropertiesrequiredforchromatographymedia.propertiesrequiredforchromatographymedia.CelluloseasaRawMaterialinCellufineCopyrightAllrightsreserved.555JNCMinamataFactoryJNCMinamataFactoryCellufineManufacturingsiteCellufineManufacturingsiteCellufineManufacturing‡HistorySince1980‡ProductionsiteJapan(Manufacturing&TechnicalSupport)‡QualitySystemISO9001(1994)ISO14001(1991)RegulatoryReferenceDocumentRawmaterialsorigin,ToxicitydataCertificateofanimalfree,StabilitydataCopyrightAllrightsreserved.6661.Stablequalityandstablesupplyareourresponsibility.2.Inordertogaintheexpectationsandsatisfactionofcustomers,allthemembersinabodywillcarryoutoperationsforthequalityassuranceandqualitycontrolactivities.3.Thecomplianceofrulesisthebasisoftheoperationsforthequalityassuranceandqualitycontrolactivities.4.Complainsandtroublesshallbequicklyandproperlyresponded.CellufineQualityPolicyCopyrightAllrightsreserved.777YearResults2009NoCriticalObservationsNoCriticalObservations2010NoCriticalObservationsNoCriticalObservations2011NoCriticalObservationsNoCriticalObservationsNoCriticalObservationsNoCriticalObservations2012NoCriticalObservationsNoCriticalObservationsNoCriticalObservationsCellufineUserAuditsHistoryUserAuditsHistoryCopyrightAllrightsreserved.888•OperatedinCleanArea•MasterBatchRecords•MaterialTraceabilityProductionQualityTestingTrainedoperatorstestintermediateandfinishedproductstoensureconformancetospecifications.IntermediatesWarehouseManufacturingPlantCellufineProductRangeAffinityHydrophobicSizeExclusionSulfatePhenylGCL‐2000PhosphateETcleanPBAminoFormylButylGH‐25ChelateMAXHydrophobicPhenyl,Butyl)IonexchangeDEAEA‐200A‐500A‐800QAQ‐500CMC‐500MAXQ‐rQ‐hMAXS‐rS‐hMAXDEAEMAXCMLinearvelocity[cm/h]Pressure[Mpa]Pressure‐flowpropertyofCellufineMAXQ‐r(2G)andCellufineQ‐500(1G)SS‐500(Inquiredproduct)CopyrightAllrightsreserved.101010CellufineMAXMAXQ‐rMedianparticlediameter90mCellufine500series(A‐500m)Medianparticlediameter90mfreaquency（％）freaquency（％）ParticleSizeandDistributionofCellufineAnalyticalequipment:HORIBALaserScatteringParticleSizeDistributionAnalyzerParticaLA‐950ParticleRangeD50MediaTypes40–130µm90MajorityofCellufineProducts125–210µm160CellufinePBCellufineAminoCellufineFormylCopyrightAllrightsreserved.1111TherapeuticantibodyProAmediaStrongCationStrongAnion(HIC)rAlbuminCellcultureStrongCationHICWeakAnionChelateCellcultureStrongAnionAffinityHAChelaterFactorIXrInsulinEnzymeconversion(premature)StrongCationRP‐HPLC(GelFiltration)FieldofCellufineinBio‐pharmaceuticalsCellcultureMAXS,S‐500MAXQ,Q‐500MAXHICMAXS,S‐500MAXPhenyl,PhenylMAXQ,Q‐500MAXDEAE,A‐500ChelateSulfateChelateMAXS,S‐500PrototypeProACopyrightAllrightsreserved.121212CellufineProductRange9CellufineIEXChromatography9CellufineHIChromatography9CellufineAffinityChromatography9CellufineGelfiltrationChromatographyCopyrightAllrightsreserved.131313OCH2CH2CH2CH2SO-Na+OOOCH2CO-Na+OOCH2CH2N+HCl-C2H5C2H5‡StrongAnionExchange(QA)‡StrongCationExchange(S)CellufineA‐200,A‐500,A‐800CellufineMAXDEAECellufineQ‐500CellufineMAXQ‐h,Q‐rCellufineC‐500CellufineMAXCMCellufineMAXS‐h,S‐rCellufineS‐500(Contactus)RCH2N+CH3Cl-CH3CH3‡WeakCationExchange(CM)‡WeakAnionExchange(DEAE)CellufineIEXMediaCopyrightAllrightsreserved.141414Conventionaltype(Cellufine500series)9Cross‐linkingtechnology9SurfacemodificationtechnologyHighCapacity&HighFlowtype(CellufineMAXseries):proteinWatersolublepolymer:Ligand:proteinWatersolublepolymer:LigandCellufineIEXMediaPoresize;200500800MAXQ‐rQ‐hMAXS‐rS‐hMAXDEAEMAXCMIonexchangeDEAEA‐200A‐500A‐800QAQ‐500CMC‐500SS‐500(Inquiredproduct)500seriesarestandardfastflowtypeCopyrightAllrightsreserved.151515‹PorosityofthebaseresinM.W.[proteins]KavA-500mA-800m　MAXDEAEAgaroseDEAEtypemedia57841975331066410％DBC-Thyro[mg/ml]10%DBC-BSA[mg/ml]A-500DEAESepharoseFFA-800MAXDEAE10%DBC‹Typicalbreak‐throughcurvebyThyroglobulin¾BaseresinofCellufineMAXhavelargerporethannormalCellufinemedia..¾Oneofhugeproteins,Thyroglobulin(MW=660kDa)canbediffusedeasilyinCellufineMAXDEAE.PropertyofBaseResininCellufineIEXMediaAgaroseDEAEtypemediaCopyrightAllrightsreserved.1616160.00.10.20.30.4050010001500Linearvelocity[cm/h]Pressure[MPa]FlowpropertyofCellufineIEXmedia(St