中国药业2024，Vol.33Issue(13)：5-11,7.DOI:10.3969/j.issn.1006-4931.2024.13.002
基于QbD理念的单克隆抗体生物类似药研发缺陷管理策略研究
Defect Management Strategies in the Research and Development of Monoclonal Antibody Biosimilars Based on QbD Concept
摘要
Abstract
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.关键词
单克隆抗体/生物类似药/质量源于设计/药品研发/缺陷管理Key words
monoclonal antibody/biosimilar/quality by design/research and development of drugs/defect management分类
医药卫生引用本文复制引用
陈罡,陈玉文..基于QbD理念的单克隆抗体生物类似药研发缺陷管理策略研究[J].中国药业,2024,33(13):5-11,7.基金项目
辽宁省经济社会发展研究课题[2020lslktyb-095]. （）
