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