抗體偶聯藥物目前主要應用于各種類型癌癥的治療。抗體偶聯藥物與其他藥物相比，其涉及抗體生產、細胞毒性小分子化學藥物生產、連接子生產、有效載荷–連接子中間體生產、抗體偶聯藥物原液與制劑生產等多個環(huán)節(jié)，其生產系統(tǒng)與傳統(tǒng)生物制品相比存在獨有的特性。從藥品生產檢查視角圍繞抗體偶聯藥物生產系統(tǒng)在生產工藝質量管控、生產過程安全防護、分段生產控制要點、污染與交叉污染控制4個方面特殊性進行分析，以期為抗體偶聯藥物生產企業(yè)做好生產系統(tǒng)質量管理提供參考與借鑒，也為該類藥品生產檢查與質量審計重點提供思路。

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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