DOI: 10.1002/ame2.12562
Application of humanized mice in the safety experiments of antibody drugs
Zhimin Sun1
Mengyun Gu2
Zixuan Yang2
Lei Shi2
Liyuan Zhao1
Minhui Zheng2
Yan Wang3
Wei Zhang1
Kexin Han1
Naping Tang4
1.College of Pharmacy,Anhui University of Chinese Medicine,Hefei,China;InnoStar Bio-Tech Nantong Co.,Ltd.,Nantong,China;Yangtze Delta Drug Advanced Research Institute,Yangtze Delta Pharmaceutical College,Nantong,China2.China State Institute of Pharmaceutical Industry,Shanghai Innostar Bio-Technology Co.,Ltd.,Shanghai,China3.InnoStar Bio-Tech Nantong Co.,Ltd.,Nantong,China;China State Institute of Pharmaceutical Industry,Shanghai Innostar Bio-Technology Co.,Ltd.,Shanghai,China4.Yangtze Delta Drug Advanced Research Institute,Yangtze Delta Pharmaceutical College,Nantong,China;China State Institute of Pharmaceutical Industry,Shanghai Innostar Bio-Technology Co.,Ltd.,Shanghai,China
摘要：Therapeutic antibodies are valued for their high specificity and selectivity in immu-notherapy.However,the potential toxicity they may elicit underscores the necessity of assessing their preclinical efficacy and safety using suitable animal models.In this context,we review the various categories and applications of humanized mice,which have been engrafted with human cells or tissues to mimic the human immune system.These models are extensively utilized in the nonclinical assessment and development of various antibody drugs,acting as a conduit to clinical research.However,several challenges remain,including the limited lifespan of humanized mice,inadequate en-graftment of human cells,and the rudimentary nature of the immune environment in these models.The development of humanized immune system models in mice pre-sents both opportunities and challenges,potentially leading to new insights into the evolution and application of antibody therapeutics.
机标关键词：applicationsafetymiceantibodydrugsexperimentshumanized
论文发表日期：2025-06-30
在线出版日期：2025-08-15（本平台首次上网日期，不代表文献的发表时间）
页数：10( 1023-1032 )
英文信息