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

  • Wei Chen
  • Wenmiao Tian
  • Yi Liang
DOI https://doi.org/10.22270/ijdra.v10i4.565

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.

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
1.
Chen W, Tian W, Liang Y. Research on Quality Control Strategy of CAR-T Cell Therapy Products based on QbD. Int J Drug Reg Affairs [Internet]. 2022Dec.15 [cited 2025Apr.29];10(4):62-4. Available from: https://www.ijdra.com/index.php/journal/article/view/565
Issue
Vol 10 No 4 (2022): VOLUME 10, ISSUE 4, 2022
Section
Research
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