PQLI_A_Mab_Case_Study_Version_2_1

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1、Version2.1th30October2009TheCMCBiotechWorkingGrouphasrequestedthatthisdocumentbeplacedinthepublicdomainbyCASSSandISPEProductDevelopmentandRealisationCaseStudyA-MabTableofContents1Introduction..........................................................................................17

2、1.1BackgroundandAcknowledgements.................................................................171.2OverallCaseStudyandDevelopmentObjectives..............................................191.3OrganizationofCaseStudy...................................................................

3、............222DesignofMoleculeandQualityAttributesAssessment.....................252.1TargetProductProfile.......................................................................................262.1.1ClinicalAspects...................................................................

4、..................262.1.2DrugProductAspects............................................................................262.2MoleculeDesign...............................................................................................262.2.1OverviewofResearchLeadingToCandidateMolecul

5、e.........................262.2.2DesignFeatures.....................................................................................272.2.3PlatformKnowledge..............................................................................272.3IdentificationandRiskAssessmentofQualityAttr

6、ibutes..................................282.3.1OverviewofaScienceandRisk-basedApproach..................................282.3.2ListofQualityAttributes.......................................................................292.4RationaleforSelectingQualityAttributesforCaseStudy.......

7、..........................302.4.1QualityAttributeRiskAssessmentTools...............................................302.4.2QualityAttributeAssessmentTool#1...................................................312.4.3QAAssessmentTool#2.....................................................

8、...................