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- W4313463810 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." @default.
- W4313463810 created "2023-01-06" @default.
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- W4313463810 date "2022-12-15" @default.
- W4313463810 modified "2023-09-27" @default.
- W4313463810 title "Research on Quality Control Strategy of CAR-T Cell Therapy Products based on QbD" @default.
- W4313463810 doi "https://doi.org/10.22270/ijdra.v10i4.565" @default.
- W4313463810 hasPublicationYear "2022" @default.
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