摘要
利用转基因小鼠技术已经产生了12个获批上市的全人源抗体药物,使其成为迄今最具优势的抗体药物研发平台。适宜基因工程改造的小鼠成为亲和力成熟全人源抗体产生的强劲引擎,其体内免疫系统自然选择与成熟机制促使产生的抗体具备成为药物的天然优势,包括高效与特异性、低免疫原性与可工艺性等。产生的系列抗体包括针对全新靶点的全新作用机制的抗体药物,也包括针对经典靶点的升级抗体药物。在传统成熟的转基因小鼠技术平台广泛应用的同时,新一代的技术平台也在不断的发展完善。
Transgenic mice have yielded twelve currently-approved full human antibody drugs, making them the most advantage platform for the discovery and development of human antibody therapeutics. Appropriately genetically-engineered mice act as robust engines for the generation of affinity-matured fully human antibodies. The use of the in vivo immune system helps driving this success by taking advantage of the natural selection and maturation process. This produces antibodies with desirable characteristics, including high potency, specificity, low risk of immunogenicity and manufacturability. A broad range of mAb drug targets are addressable in these mice, comprising both innovator drugs targeting to new targets and biobetters targeting to classic targets. While the originator transgenic mice platforms are broadly available, a new generation of transgenic platforms is in development for discovery of the next wave of human therapeutic antibodies.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2016年第22期2596-2602,共7页
Chinese Journal of New Drugs
基金
国家"重大新药创制"科技重大专项资助项目(2014ZX09201041)
河北省科技计划项目(16272401D)