摘要
目的对帕妥珠单抗关键质量控制项目进行趋势分析,为单抗药物的质量评价及监督提供依据。方法通过建立警戒线(x±2 SD)、行动限(x±3 SD)和绘制趋势分析图,对中国食品药品检定研究院(National Institutes for Food and Drug Control,NIFDC)及企业质控实验室2019—2022年89批帕妥珠单抗的生物学活性、蛋白质含量、单体含量、p H等质量控制项目进行趋势分析和统计学分析。结果NIFDC与企业生物学活性均值分别为(1.06±0.15)×10^(4)U/mg和(1.04±0.06)×10^(4)U/mg;蛋白质含量均值分别为(30.57±0.49)mg/m L和(30.84±0.20)mg/m L;分子排阻色谱单体峰面积均值分别为(99.80±0.00)%和(99.80±0.01)%;p H均值分别为6.06±0.06和6.07±0.04。对上述结果进行连续性趋势分析,总体趋势较平稳。结论对帕妥珠单抗的部分关键质量属性的趋势分析,间接反映出该制品生产工艺稳定、批间一致性良好。趋势分析可有效对单抗药物生产和质量控制起到监测和提示作用。
Objective To conduct the trend analysis in some critical quality attributes(CQAs)of Pertuzumab,so as to provide a basis for the quality evaluation and supervision of monoclonal antibodies.Methods By establishing warning limit(x±2 SD),action limit(x±3 SD)and drawing trend analysis chart,the trend analysis and statistical analysis on the biological activity,protein content,monomer content and p H of 89 batches of Pertuzumab detected by National Institutes for Food and Drug Control(NIFDC)and the manufacturer quality control laboratory from 2019 to 2022 were performed.Results The mean values of NIFDC and manufacturer for biological activity potency were(1.06±0.15)×10^(4)U/mg and(1.04±0.06)×10^(4)U/mg;the mean values for protein content were(30.57±0.49)mg/m L and(30.84±0.20)mg/m L;the mean values of the monomer peak areas of molecular exclusion chromatography were(99.80±0.00)%and(99.80±0.01)%;and the mean values of p H were 6.06±0.06 and 6.07±0.04,respectively.Continuity trend analysis of the above results showed that the overall trend was smooth.Conclusion The trend analysis on some CQAs of Pertuzumab reflected stable production process and good batch to batch consistency of the product indirectly,which can be effective for monitoring and suggesting the production and quality control of monoclonal antibody drugs.
作者
崔春博
刘春雨
武刚
徐刚领
杜加亮
崔永霏
俞小娟
喻钢
杨雅岚
王兰
CUI Chunbo;LIU Chunyu;WU Gang;XU Gangling;DU Jialiang;CUI Yongfei;YU Xiaojuan;YU Gang;YANG Yalan;WANG Lan(Division of Monoclonal Antibody Products,National Institutes for Food and Drug Control,Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products,Key Laboratory of the National Medical Products Administration for Research on Quality Study and Evaluation of Biological Products,Bejing 102629,China)
出处
《中国生物制品学杂志》
CAS
CSCD
2024年第11期1319-1326,共8页
Chinese Journal of Biologicals
基金
国家重点研发计划(2021YFF0600804)。
关键词
帕妥珠单抗
质量控制
生物学活性
蛋白质含量
分子排阻色谱
PH值
趋势分析
Pertuzumab monoclonal antibody
Quality control
Biological activity
Protein content
Molecular exclusion ch matography
pH
Trend analysis
