华东理工大学学报（自然科学版）2017，Vol.43Issue(6)：806-814,9.DOI:10.14135/j.cnki.1006-3080.2017.06.009
CHO细胞培养生产抗体产量的稳定性
Titer Stability of Antibody Produced by CHO Cell Culture
张进 1王星懿 1范里 1谭文松1
作者信息
- 1. 华东理工大学生物工程学院,生物反应器工程国家重点实验室,上海200237
- 折叠
摘要
Abstract
The stability of Chinese hamster ovary (CHO) cells during high density cultivation process was realized.The fed-batch culture process expressing IgG antibody was studied based on QbD theory.Firstly,potential critical control parameters were dissected by using "fishbone diagram" analysis and Failure Mode and Effect Analysis (FMEA).Secondly,key control parameters were determined and their design ranges were optimized by DOE (Design of experiment) method.Results show that eight key control parameters and their scope were searched and confirmed within 99 cell culture process parameters.Through optimization and control,difference of antibody titer between batches of fed-batch culture process decreases from 200％ to 10％.Based on QbD theory,it can rapidly and effectively achieve process stability of antibody production by CHO cell culture which is benefit for the safety of antibody drug production and the economic benefits of enterprises.关键词
细胞培养技术/QbD/FMEA/设计范围/过程控制Key words
cell culture technology/QbD/FMEA/design space/process control分类
生物科学引用本文复制引用
张进,王星懿,范里,谭文松..CHO细胞培养生产抗体产量的稳定性[J].华东理工大学学报（自然科学版）,2017,43(6):806-814,9.
