Progress in residual DNA in biological products
10.19778/j.chp.2024.05.001
- VernacularTitle:生物制品中宿主细胞残留DNA的检测研究进展
- Author:
Shuqiang ZHAO
1
;
Jingyuan GAO
;
Doudou LOU
;
Qinglin PANG
;
Qingshui SHI
;
Yihong LU
Author Information
1. 江苏省食品药品监督检验研究院,国家药品监督管理局化学药品杂质谱研究重点实验室,南京 210019
- Keywords:
biological products;
residual DNA;
critical quality attributes;
process impurities;
quality by design
- From:
Drug Standards of China
2024;25(5):437-442
- CountryChina
- Language:Chinese
-
Abstract:
Host cell residue DNA is one of the most common impurity which can affect the safety of biological products,therefore,domestic and international regulatory agencies have required the limit for host cell residue DNA in different biological products,either at the final product qualification or the appropriate intermediate control stage.The removal effect is verified by monitoring the residue DNA of products in different production stages,which is beneficial for assuring the scientificity and stability of the production process.In order to strengthen the understanding of control strategy about host cell residual DNA,the paper reviews progress in host cell residual DNA in biological products by authors'work experience and other's research,which provides reference for future work.
