抗体偶联药物目前主要应用于各种类型癌症的治疗。抗体偶联药物与其他药物相比，其涉及抗体生产、细胞毒性小分子化学药物生产、连接子生产、有效载荷–连接子中间体生产、抗体偶联药物原液与制剂生产等多个环节，其生产系统与传统生物制品相比存在独有的特性。从药品生产检查视角围绕抗体偶联药物生产系统在生产工艺质量管控、生产过程安全防护、分段生产控制要点、污染与交叉污染控制4个方面特殊性进行分析，以期为抗体偶联药物生产企业做好生产系统质量管理提供参考与借鉴，也为该类药品生产检查与质量审计重点提供思路。

Antibody-drug conjugates are currently mainly used for the treatment of various types of cancer. Compared with other drugs, antibody-drug conjugates involve multiple stages such as antibody production, cytotoxic small molecule chemical drug production, linker production, payload linker intermediate production, antibody-drug conjugate bulk solution and formulation production. Antibody-drug conjugates production system has unique characteristics compared to traditional biological products. This article analyzes the particularity of the antibody-drug conjugates production system from the perspective of drug production inspection, focusing on four aspects: production process quality control, safety protection during the production process, key control points for segmented production, and contamination and cross-contamination control. The aim is to provide reference and guidance for antibody-drug conjugates production enterprises to further improve production system quality management, and also to provide ideas for the key points of production inspection and quality audit of antibody-drug conjugates.

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