Research on Quality Control Strategy of CAR-T Cell Therapy Products based on QbD

  • Wei Chen
  • Wenmiao Tian
  • Yi Liang


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.

Keywords: QbD, CAR-T cell therapy, Critical quality attributes, Critical process parameters, NMPA, quality target product profile (QTPP), Kymarih


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How to Cite
Chen, W., W. Tian, and Y. Liang. “Research on Quality Control Strategy of CAR-T Cell Therapy Products Based on QbD”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 4, Dec. 2022, pp. 62-74, doi:10.22270/ijdra.v10i4.565.