浅析抗体偶联核素类产品药学研发和评价关注点

The concerns of CMC research and evaluation of antibody radionuclide conjugates products

抗体偶联核素药物(antibody radionuclide conjugates,ARC)采用的放射性核素与抗体通过连接臂和螯合剂偶联,可以发挥体内诊断或治疗等不同功能。目前,ARC作为放射性核素偶联药物(radionuclide drug conjugates,RDC)重要的产品类型,正在开展临床试验的候选药物数量较多。但是,国内工业界在开发临床应用级ARC产品时面临诸多挑战。因此,本文总结了ARC产品的相关法规及最新研究进展,从生产工艺、质量研究与控制、稳定性等方面对此类产品的药学研究与评价的关注点展开讨论,以期促进此类产品的临床转化与应用。

Antibody radionuclide conjugates(ARC)conjugate radionuclides and antibodies through a linker and chelator,which can perform different functions of diagnosis or treatment.To date,ARC is an important product type of radionuclide drug conjugates(RDC),and there are many approved drugs and drug candidates in clinical trials.However,the domestic industry faces many challenges in the development of clinical application-grade ARC products.This article summarizes the latest research progress of ARC products,from raw materials,production process and quality control,expecting to promote the clinical transformation and application of such products.