生物分离工程-双语版-8资料讲解.ppt

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1、生物分离工程-双语版-8Downstreamprocessingequipment120%ofequipmentsgrowperyear(1.0billion$(1991)to5.2billion$(2000)2Keytocuttingproductioncost:(1)Improvementinbioseparationequipments(2)UpstreamprocessAminorchangesinupstreamsignificantlyimpacteconomicorotherwiseBpurificationprocessmu

2、stconsiderupstreamBringadrugtomarket1Cost:$100millionto$300million(1985-1992),350$to400million(1995)2Time:7to10years3Research-focusedcompaniescombinedwithdrugdevelopment,manufacturingandmarketingresources(1)1to3fullyintegratedbiopharmaceuticalcompanies,(2)10-15platformcomp

3、anies(3)50-100successfulboutiques(小商店，小公司）4Allergan($1billioninannualsales)combiningLigand(13millioninannualresearchrevenues）.DevelopmenttimeofbiopharmaceuticalsfromFDA1Developmenttimeofdrugs(1)4-10years(~7years),largepartofdrugs(2)7-23years(~12years),smallpartofdrugs2Risk

4、sandfinancialsupport(1)Fewbiotechnologycompanieswereprofitablein1993(2)Considerableeffortondevelopingcredibility,andappealingtoinvestorstoattractcapital.3VerylittleeffortonconsumerneedsandmarketsBiotechnologicalproductreadyformarket1conformtoFDAstandard2safe,potentandpure3

5、stableininjectableform4minimizethenumberofstepswhilemaintaininghighyieldsandproductpurity,qualityandactivityAreducetheopportunityofproductlossBminimizeproductcontamination.Processdevelopmentconsideraton1purpose2goals3standards4properties5nativeenvironment6source7Preventunn

6、ecessaryandunexpectedlossofactivityDownstreamprocessingcostsplayamajorrole1manyacademicandlaboratoryeffortsarefocusedontheisolationofaparticularproduct2scantattentionispaidtotheeconomicsofprocess3operationaldatafromlaboratoryandpilotplantarerarelyreportedDifficulties1Notal

7、lthevariablesarecompletelyknownastheprocessisscaled-up.2Thereshouldbeenoughflexibilityintheprocesstotakecareoftheunexpectedneeds.Centrifugation1Inbiotechnology,centrifugationiseffectivelyusedtoseparateproductsthatexhibitverysmalldifferencesin]specificgravity.2Compactlydesi

8、gnedcentrifugeshaveefficienteconomiesofscale.3CostsEconomicconsiderationsareakeyfactorinu