Considerations for quality study of recombinant protein-based radiopharmaceuticals
QIU Xiao
KOU Ya-zhen
WANG Xue
CHEN Hao
ZHANG Meng-meng
HE Wu
Abstract：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.
Keywords：recombinant proteinradionuclideradiolabeldrug developmentquality study
Publication Date：2025-03-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 596-601 )