Development and evaluation considerations of viral vector production for CAR-T cell products
10.3872/j.issn.1007-385x.2018.12.002
- VernacularTitle:CAR-T细胞产品中病毒载体生产的研发进展和审评考虑
- Author:
XU Longchang
1
;
WEI Wei
1
;
LUO Jianhui
1
Author Information
1. （Center for Drug Evaluation, National Medical ProductsAdministration
- Publication Type:Journal Article
- Keywords:
chimeric antigen receptor T (CAR-T) cell;
viral vector;
lentivirus;
retrovius;
research and development;
review
- From:
Chinese Journal of Cancer Biotherapy
2018;25(12):1218-1222
- CountryChina
- Language:Chinese
-
Abstract:
Due to the spectacular therapy results in hematologic tumors, chimeric antigen receptor T (CAR-T) cell therapy has been the research hot-spot in the field of cell-immunotherapy. Viral vectors, as the critical raw material in CAR-T cell manufacturing, are closely related to the safety, efficacy and quality control of CAR-T cell products, in the aspects of the structure design of CAR gene, refinement of production process, quality control and setting of characterization and specification etc. Based on the research progress in lentiviral and γ-retroviral vectors development and the evaluation experiences, this paper discusses some common problems that need to be focused on in the preparation of viral vectors, expecting to provide references for the development and the authorization applications of domestic related products in the future.
- Full text:20181202.pdf
