重组抗体药物研究进展及应用

重组抗体药物的发展经历了鼠源单克隆抗体（McAb）、人 鼠嵌合抗体、人源化抗体和全人抗体等阶段，目前初步应用于抗肿瘤、抗自身免疫病、抗感染等领域。保持和提高抗体的亲和力、降低抗体的免疫原性是抗体药物基因工程改造的两大原则。在嵌合抗体成功的基础上，通过CDR移植、表面修饰、抗体库以及转基因鼠技术，逐步提高人源化程度至100%。然而，实验室水平的研究结果与实际应用仍然存在一定差距。就重组抗体药物的基本概况、现存的问题与可能的解决办法以及在肿瘤、病毒性疾病和阿尔茨海默病治疗上的应用情况等进行了综述。

Advances and Applications of Recombinant Antibody Drugs

Recombinant antibody drugs has developed through mice monoclonal antibody（McAb）, human mice chimeric antibody, humanized antibody and full human antibody. They have been applied in clinical immunotherapy for the treatment of cancer, autoimmune diseases, viral diseases and Alzheimer disease, etc. The two basic principles in antibody humanization are keeping or enhancing affinity and reducing immunogenicity of engineered antibodies. The degree of humanization has approached 100% following the continuously improved techniques, such as CDR grafting, resurfacing, antibody library and transgenic mice. However, the gap between the basic research and clinical application still need to be filled. The outline, challenge and perspective in application associated to recombinant antibody drugs were reviewed here.