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1、TechnicalReportNo.42ProcessValidationofProteinManufacturing技术报告42号蛋白制造工艺验证PDAJournalofPharmaceuticalScienceandTechnology注射用药物协会杂志-制药科学与技术2005年9/10增刊59卷S-4蛋白制造工艺验证工作组成员：ChrisBussineau,Ph.D.,ChironCorporation,Co-ChairRobertSeely,Ph.D.,Amgen,Inc.,Co-ChairGenevie
2、veLovitt,G.I.Lovitt&Associates,ProjectManager/TechnicalEditorJamesFernandez,FernandezandAssociates,PDALiaisonGregBlank,Ph.D.,Genentech,Inc.E.J.Brandreth,Favrille,Inc.ChrisBussineau,Ph.D.,ChironCorporationDorisConrad,Consultant,GlaxoSmithKlineBiologicalsRebecc
3、aA.Devine,Ph.D.,IndependentRegulatoryConsultantRobertJ.Ferris,Ph.D.,ChironCorporationKoendeHeyder,GlaxoSmithKlineBiologicalsRobertW.Juffras,M.S.,WyethBioPharmaPeterLevy,MillenniumPharmaceuticals,Inc.WolfgangList,Ph.D.,AventisBehringMortenMunk,CMCBiopharmaceut
4、icalsA/SBrianC.Neely,DonHillandAssociates,Inc.StephenNotarnicola,Ph.D.,BiogenIdecRhonaO’Leary,Ph.D.,Genentech,Inc.HaroldvanDeinse,BaxterHealthcareCorporationTableofContents目录1Introduction简介......................................................................
5、...........................................................................................31.1Purpose目的...........................................................................................................................................................
6、....31.2Scope范围..................................................................................................................................................................32Definitions定义....................................................................
7、................................................................................................43ProcessValidationPrerequisites工艺验证前提条件......................................................................................................83.1Introduction简介...
8、....................................................................................................................................................83.2Planning计划制定.......................
