摘要
市场高达数千亿美元的单克隆抗体药物即将结束专利保护期,这对发展中国家产业升级,提高国民医疗水平,都是一次难得的战略机遇。然而,单抗类蛋白仿制药的研发与质控工作难度巨大,必须使用液相色谱-质谱联用技术进行分析。针对单抗仿制药结构必须进行的分析项目(氨基酸序列表达正确性、糖基化修饰形态相似性、以及高级结构统一致性)的液质分析方法进行了系统介绍。此外还就分析工作效率及质控过程的法规依从问题予以讨论。
The patent protection period of many monoclonal antibody drugs will expire,which market value will be over a hundred billion dollars.It is very important for developing countries to improve their medical system and upgrade industries.But,there are huge difficulties in developing biosimilar monoclonal antibody,which must use LCMS system to overcome.How to use LCMS system to get required data item for biosimilar monoclonal antibody was shown.Besides techniques,the work efficiency and law requirements for biosimilar drug production were also discussed.
出处
《中国生物工程杂志》
CAS
CSCD
北大核心
2012年第10期93-98,共6页
China Biotechnology
