一次性使用系统(single use system，SUS) 具有简便、灵活、成本低等优势，广泛用于抗体药物的工艺开发和商业化生产中。但是，在抗体药物的生产过程中，SUS 或组件会产生可提取物和浸出物(extractables and leachables，E&L)，影响产品质量，给患者的健康带来风险。因此，在药物上市申报前，需对SUS 进行E&L 研究，以证明其控制策略和安全性。近年来，随着抗体制药行业的不断发展与完善，国内外法规对E&L 研究的要求也越来越高。本文总结了E&L 相关的法规与行业要求，并结合抗体药物在国内外成功申报的经验，详细介绍了E&L 的研究思路和考量，包括信息收集、风险评估、E&L 研究和安全性评估。
Abstract
The single use system(SUS) is widely used in the process development and commercial production of antibody drugs due to its simplicity, flexibility, and cost advantages. However, in the production process of antibody drugs, SUS or its components will produce extractables and leachables(E&L), which can affect the quality of the product and bring risks to the health of patients. Therefore, it is necessary to conduct E&L researches on SUS before the application of the drug on the market to prove its control strategy. In recent years, with the continuous development and improvement of the antibody pharmaceutical industry, domestic and foreign laws, as well as the regulations have raised more and more requirements for E&L research. In this review, E&L-related regulations and industry requirements were summarized with the experience of successful application of antibody drugs at home and abroad. The research ideas and considerations of E&L were introduced in detail, including information collection, risk assessment, E&L researches and safety assessment.
关键词
单克隆抗体治疗 /
一次性使用系统 /
可提取物 /
浸出物
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Key words
monoclonal antibody therapeutics /
single use system /
extractables /
leachables
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