放射性核素标记重组蛋白类产品的质量研究考虑  

Considerations for quality study of recombinant protein-based radiopharmaceuticals

作　　者：邱晓 寇雅真 王雪 陈昊 张梦梦 何伍 QIU Xiao;KOU Ya-zhen;WANG Xue;CHEN Hao;ZHANG Meng-meng;HE Wu(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China;State Key Laboratory of Drug Regulatory Science,Beijing 102629,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076 [2]药品监管科学全国重点实验室,北京102629

出　　处：《中国新药杂志》2025年第6期596-601,共6页Chinese Journal of New Drugs

基　　金：药品监管科学全国重点实验室课题项目(2024-SKLDRS0101)。

摘　　要：放射性核素标记重组蛋白类产品同时具有重组蛋白类产品的靶向性及放射性核素的特点,可用于诊断或治疗。放射性核素标记重组蛋白类产品的开发过程非常复杂,为了使产品具备预期的半衰期、放射性特性和代谢途径,应该谨慎选择重组蛋白、放射性核素和标记方法。本文汇总了用于放射性核素标记重组蛋白类产品的重组蛋白、放射性核素、标记方法的特点及开发的考量,并结合该类产品的特点阐述了产品质量研究的考量。Recombinant protein-based radiopharmaceuticals,which can be used for imaging and therapy,utilize the characteristics of recombinant protein and radionuclide,thus can target antigens with high specificity and exhibit radioactivity.The path to develop recombinant protein-based radiopharmaceuticals is complex.Recombinant proteins,radionuclides,and labeling methods should be carefully selected to ensure that the final product possesses the desired half-life,radioactive properties,and metabolic pathways.In this paper,we summarize the characteristics of recombinant proteins,radionuclides,and labeling methods used for recombinant protein-based radiopharmaceuticals.To guarantee a reproducible quality of the radiolabeled product,the considerations for the quality study are described.

关 键 词：重组蛋白 放射性核素 放射标记 药物开发 质量研究 

分 类 号：R95[医药卫生—药学]