In:
International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 4 ( 2022-12-15), p. 62-74
Abstract:
Objective: This paper aims to provide reference for how to use the concept and method of QbD to control the quality of CAR-T cell therapy products in the commercial production of CAR-T cell therapy products in China, and how to formulate reasonable and effective quality control strategies. Methods: This paper systematically analyzes the industrial development of CAR-T cell therapy products and the concept, application methods and implementation process of QbD in China through literature research and case analysis theory Results: Cell therapy products are a hot area in the research and development of new drugs, but at present, there are no specific regulatory rules in the commercial production of CAR-T cell therapy products in China, the awareness of risk control is weak, and the quality control is unstable, making patients face many risks. Conclusion: Based on the concept of QbD, the quality control strategy of CAR-T cell therapy products was proposed from three dimensions.
Type of Medium:
Online Resource
ISSN:
2321-6794
,
2321-7162
DOI:
10.22270/ijdra.v10i4.565
Language:
Unknown
Publisher:
Society of Pharmaceutical Tecnocrats
Publication Date:
2022
detail.hit.zdb_id:
2738279-5
SSG:
15,3
