制定单克隆抗体规格.pdf

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1、中国食品药品检定研究院National Institutes for Food and Drug ControlEstablishment of Specifications for Monoclonal AntibodiesChuanfei Yu PhDNational Institutes for Food and Drug ControlDisclaimerDisclaimer:This report represents only personal views and does not reflect the opinions of the regulatory authorities

2、 or the National Institutes for Food and Drug Control.National Institutes for Food and Drug Control1OverviewCompendial and regulatory requirements and experience with similar productsExamples of specification setting for purity and potencyReport Outline23Summary4National Institutes for Food and Drug

3、 ControlOverall Control Strategy for BiologicsICH Q6BNational Institutes for Food and Drug ControlComprehensive method validationICH Q6BOverall Control Strategy for BiologicsNational Institutes for Food and Drug ControlConsiderations for Specification Item SettingUsing the QbD approach,lot release&s

4、tability testing should berisk-based and address highly critical or less well-controlled attributesA specification is defined as a list of tests,references to analytical procedures,and appropriate acceptance criteria which are numerical limits,ranges,or other criteria for the tests described.ICH Q6B

5、National Institutes for Food and Drug ControlTypical Specification for Monoclonal AntibodiesNational Institutes for Food and Drug ControlICH-Q6BLinked to Manufacturing Process-Proposed specification should be based on data from manufacturing process with demonstrated manufacturing consistency.-A lac

6、k of manufacturing consistency is not a good justification for a broad specification.Account for drug substance and drug product stability-May need serval stability indicating assays to address the inherent product complexity.Linked to preclinical and clinical studies-The quality of commercial scale