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| 单抗注册生产现场检查中的一般考虑 |
| Xu Dan, Zhou yan, Duan shuang, Wang yuan* |
| 投稿时间：2020-04-17 修订日期：2020-09-28 |
| DOI： |
| 中文关键词: 单抗 注册现场检查 质量工艺控制 |
| 英文关键词: antibody pre-approval inspection quality control of process |
| 基金项目: |
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| 摘要点击次数: 524 |
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| 中文摘要: |
| 目的 通过探讨单抗生产质量控制中的常见问题,提出单抗注册生产检查中的关注点,为单抗注册生产现场检查统一检查标准。方法 以多年的药品检查工作实践为基础, 结合抗体的生物学特点,从“注册现场检查”的角度分析单抗质量控制和生产中存在的问题。结果与讨论 从基于体系的横向检查策略和基于品种的纵向检查策略两个维度,明确单抗生产中的关键质控点和统一检查标准,与业界达成共识,共同促进国内抗体的工艺控制和质量水平。 |
| 英文摘要: |
| Objective :Through the discussion of common problems in the quality control of antibody, the focus in the pre-approval inspection of antibody was identified, and the inspection standard for the field was uniformed. Methods:Based on the practice of the pre-approval inspection of antibody and the knowledge of biological characteristics for antibodies, it has been analyzed the problems in the quality control and production of antibody. Results and Conclusion:From the two dimensions of system-based horizontal inspection strategy and variance-based vertical inspection strategy, the key points of quality and inspection standards in the production of antibody were identified, in order to make a consensus with the industry and promote the process control and quality level of domestic antibodies. |
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