The Discussion of Regulatory Inspection Key Points Based on the Production Technology of Immune Cell Therapy Products
Objective:To review and summarize the development and regulatory inspection documents of immune cell therapy products,and provide reference for the production and supervision of such products.Methods:The production characteristics of immune cell therapy products were organized and analyzed,and regulatory guidelines and reference documents in China were introduced,some key points that need to be taken into account by on-site inspections for this type of products were also summarized.Results and Conclusion:Compared with traditional drugs,cells as drug have multiple unique characteristics.Therefore,there are challenges in production management,quality control,and systemic contamination risks caused by different products to be produced on the same line.This article proposes suggestions for on-site inspection and risk assessment of immune cell therapy products from the perspective of provincial regulatory authorities,combined with the production process of immune cell therapy products.We hope to further improve the post-marketing supervision system of immune cell therapy products.
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