Defect Management Strategies in the Research and Development of Monoclonal Antibody Biosimilars Based on QbD Concept
Objective To provide a reference for the early research and development(R&D)management of biosimilars.Methods Based on the R&D and application practice of Adalimumab monoclonal antibody biosimilars,combined with relevant regulations,guiding principles,and evaluation cases,the pharmaceutical research deficiencies in the R&D process of monoclonal antibody biosimilars were analyzed from the perspective of pharmaceutical supervision.Based on the concept of Quality by Design(QbD),corresponding defect management strategies were proposed for the comprehensiveness of product quality attribute research,scientificity of process control,adequacy of safety assessment of exogenous factors,completeness of stability research,and standardization of research data.Results and Conclusion The research deficiencies mainly manifest in five aspects:incomplete research on drug quality attributes,unscientific process control,insufficient safety assessment of exogenous factors,incomplete stability research,and non-GXP compliant research data.On the premise of fully studying the product quality attributes,defect management is implemented through product design-process control-quality implementation to improve the R&D efficiency of biosimilars,and the quality of product research and application.
monoclonal antibodybiosimilarquality by designresearch and development of drugsdefect management
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