中国兽药杂志2025，Vol.59Issue(4)：24-31,8.DOI:10.11751/ISSN.1002-1280.2025.4.04
兽用治疗用单克隆抗体开发及评价要点分析
Veterinary Monoclonal Antibody Development and Evaluation:A Key Points Analysis
邱基程 1张璐 1赵静 2张福成 3苏富琴 4曹兴元1
作者信息
- 1. 中国农业大学动物医学院,北京 100193||中国农业大学国家兽药安全评价中心,北京 100193
- 2. 北京市朝阳区动植物疾病预防控制中心,北京 100024
- 3. 北京市动物疫病预防控制中心,北京 102629
- 4. 中国兽医药品监察所(农业农村部兽药评审中心),北京 100081
- 折叠
摘要
Abstract
Monoclonal antibodies are of crucial importance in disease treatment due to their outstanding advantages of high specificity,diversity,and a low adverse reaction rate.Their high specificity enables them to act precisely on targets,reducing damage to normal cells;diversity supports the formulation of diverse treatment plans for different diseases and pathogenesis.Monoclonal antibodies have been widely applied in the treatment of tumor diseases,immune system diseases,and viral infectious diseases,with excellent clinical effects and extremely high development value.In contrast,the development of veterinary therapeutic monoclonal antibodies is relatively lagging and is still in the initial stage.There is a wide variety of animal species,and the physiological characteristics,metabolic patterns,and immune responses of different animals vary greatly,and the disease models are complex.These factors pose many challenges to the research and development of veterinary monoclonal antibodies.Currently,there are still a large number of gaps in the research methods and technologies for veterinary therapeutic monoclonal antibody drugs.Based on the relevant requirements of the European Union,this review deeply analyzes their scientific basis,sorts out the development and evaluation processes of the veterinary therapeutic monoclonal antibodies that have been launched on the market abroad,and conducts multi-dimensional analyses from aspects such as research and development ideas,technical key points,and experimental design,providing references for the development and evaluation of this field and contributing to its development.关键词
创新型新兽药/兽用治疗用单克隆抗体/药物开发和评价Key words
innovative veterinary medicine/veterinary monoclonal antibodies/drug development and evaluation分类
农业科技引用本文复制引用
邱基程,张璐,赵静,张福成,苏富琴,曹兴元..兽用治疗用单克隆抗体开发及评价要点分析[J].中国兽药杂志,2025,59(4):24-31,8.
