Application of humanized mice in the safety experiments of antibody drugs
Abstract Therapeutic antibodies are valued for their high specificity and selectivity in immunotherapy. 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 ca...
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| Format: | Article |
| Language: | English |
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Wiley
2025-06-01
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| Series: | Animal Models and Experimental Medicine |
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| Online Access: | https://doi.org/10.1002/ame2.12562 |
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| author | Zhimin Sun Mengyun Gu Zixuan Yang Lei Shi Liyuan Zhao Minhui Zheng Yan Wang Wei Zhang Kexin Han Naping Tang |
| author_facet | Zhimin Sun Mengyun Gu Zixuan Yang Lei Shi Liyuan Zhao Minhui Zheng Yan Wang Wei Zhang Kexin Han Naping Tang |
| author_sort | Zhimin Sun |
| collection | DOAJ |
| description | Abstract Therapeutic antibodies are valued for their high specificity and selectivity in immunotherapy. 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 engraftment of human cells, and the rudimentary nature of the immune environment in these models. The development of humanized immune system models in mice presents both opportunities and challenges, potentially leading to new insights into the evolution and application of antibody therapeutics. |
| format | Article |
| id | doaj-art-1f52ef1a94e2424ab5b2d59dab3250aa |
| institution | Matheson Library |
| issn | 2576-2095 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Wiley |
| record_format | Article |
| series | Animal Models and Experimental Medicine |
| spelling | doaj-art-1f52ef1a94e2424ab5b2d59dab3250aa2025-06-28T04:48:14ZengWileyAnimal Models and Experimental Medicine2576-20952025-06-01861023103210.1002/ame2.12562Application of humanized mice in the safety experiments of antibody drugsZhimin Sun0Mengyun Gu1Zixuan Yang2Lei Shi3Liyuan Zhao4Minhui Zheng5Yan Wang6Wei Zhang7Kexin Han8Naping Tang9College of Pharmacy Anhui University of Chinese Medicine Hefei ChinaChina State Institute of Pharmaceutical Industry Shanghai Innostar Bio‐Technology Co., Ltd. Shanghai ChinaChina State Institute of Pharmaceutical Industry Shanghai Innostar Bio‐Technology Co., Ltd. Shanghai ChinaChina State Institute of Pharmaceutical Industry Shanghai Innostar Bio‐Technology Co., Ltd. Shanghai ChinaCollege of Pharmacy Anhui University of Chinese Medicine Hefei ChinaChina State Institute of Pharmaceutical Industry Shanghai Innostar Bio‐Technology Co., Ltd. Shanghai ChinaInnoStar Bio‐Tech Nantong Co., Ltd. Nantong ChinaCollege of Pharmacy Anhui University of Chinese Medicine Hefei ChinaCollege of Pharmacy Anhui University of Chinese Medicine Hefei ChinaYangtze Delta Drug Advanced Research Institute Yangtze Delta Pharmaceutical College Nantong ChinaAbstract Therapeutic antibodies are valued for their high specificity and selectivity in immunotherapy. 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 engraftment of human cells, and the rudimentary nature of the immune environment in these models. The development of humanized immune system models in mice presents both opportunities and challenges, potentially leading to new insights into the evolution and application of antibody therapeutics.https://doi.org/10.1002/ame2.12562antibody drugshumanized miceimmunogenicitypreclinical evaluation |
| spellingShingle | Zhimin Sun Mengyun Gu Zixuan Yang Lei Shi Liyuan Zhao Minhui Zheng Yan Wang Wei Zhang Kexin Han Naping Tang Application of humanized mice in the safety experiments of antibody drugs Animal Models and Experimental Medicine antibody drugs humanized mice immunogenicity preclinical evaluation |
| title | Application of humanized mice in the safety experiments of antibody drugs |
| title_full | Application of humanized mice in the safety experiments of antibody drugs |
| title_fullStr | Application of humanized mice in the safety experiments of antibody drugs |
| title_full_unstemmed | Application of humanized mice in the safety experiments of antibody drugs |
| title_short | Application of humanized mice in the safety experiments of antibody drugs |
| title_sort | application of humanized mice in the safety experiments of antibody drugs |
| topic | antibody drugs humanized mice immunogenicity preclinical evaluation |
| url | https://doi.org/10.1002/ame2.12562 |
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