| 许丹,周艳,段爽,王元.探讨单抗注册生产现场检查中的质量控制要点[J].中国药事,2020,34(10):1115-1123 |
| 探讨单抗注册生产现场检查中的质量控制要点 |
| Analysis of Quality Control in the Pre-approval Inspection of Antibody Products |
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| DOI：10.16153/j.1002-7777.2020.10.001 |
| 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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| 中文摘要: |
| 目的：探讨单抗生产质量控制中的常见问题，指出单抗注册生产检查中的关注点，统一单抗注册生产现场检查标准。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。结果与结论：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，共同提高国内抗体的工艺控制水平和质量水平。 |
| 英文摘要: |
| Objective: To discuss the common issues in the manufacture and quality control of antibodies, to point out the concerns in monoclonal antibody production registration inspection, and to unify the standards of pre-approval inspection of antibodies. Methods: Based on the practice of the pre-approval inspection and the knowledge of biological characteristics of antibodies, issues in the quality control and production of antibodies were analyzed from the registration field inspection perspective. Results and Conclusion: From the two dimensions of system-based horizontal inspection strategy and product-based vertical inspection strategy, the key quality control points and unified inspection standards in the production of antibodies were identified, a consensus was reached with the industry and the improvement of process control and quality level of domestic antibodies were jointly promoted. |
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