Considerations and application status of selection marker for generation of recombinant biologics producing mammalian cell lines
10.16438/j.0513-4870.2020-0454
- VernacularTitle:重组蛋白药物生产用哺乳动物细胞系构建中筛选标记的应用现状及审评思考
- Author:
Ying CUI
;
Yu BAI
;
Su-yuan CHENG
- Publication Type:Research Article
- Keywords:
recombinant biologics;
CHO cell;
selection marker;
selection stringency;
cell substrate stability;
selection marker safety
- From:
Acta Pharmaceutica Sinica
2020;55(12):2989-2993
- CountryChina
- Language:Chinese
-
Abstract:
The major challenge in the development of recombinant biologics lies in generating and isolating rare high-producing stable single clone in a short period of time. The selection marker is an essential component of the plasmid vector, it plays an important part in the generation and screening of producing cell lines. Engineering the selection marker to enhance the stringency of selection for high producing cells is one of the most effective approaches to improve the cell line development process. Here, using Chinese hamaster overy (CHO) cells as an example, we introduce the application of selection marker for generation of recombinant biologics producing mammalian cell lines, methods of engineering the selection markers to enhance the selection stringency, and propose considerations on cell substrate stability and selection marker safety, in order to provide references for high-efficiency development of recombinant biologics.