School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, Jiangsu Province 210000, China
Online published on 9 February, 2023.
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.
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
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.
Based on the concept of QbD, the quality control strategy of CAR-T cell therapy products was proposed from three dimensions.
QbD, CAR-T cell therapy, Critical quality attributes, Critical process parameters, NMPA, Quality target product profile (QTPP), Kymarih
