生物药物分析方法验证体系的研究

Study on Validation System for Biopharmaceutical Analytical Methods

目的:探讨生物药物分析方法验证中存在的问题及改良策略。方法:分析国内外对于生物药物分析方法验证的理念、特点及研究进展,将质量源于设计的理念同传统方法验证理念进行比较研究。结果与结论:将指标化、终点化控制的传统验证体系改良为可视化、可溯源、立体化过程控制的方法验证系统。将方法建立及验证工作有机融合一体,为高质量数据提供保障。这个体系不但可有效整理记录方法建立及验证过程,利于分析方法转移过程中有效信息的传递,也有利于生物药物分析方法的评价和研究。

Objective： To investigate drawbacks and measures for improving of validation of biopharmaceutical analytical methods. Methods： The concept, characteristics and research progress of validation of analytical methods in worldwide biopharmaceutical researches were studied, and the novel concept of ＇quality by design＇ was compared with the traditional concept on method validation. Results and Conclusion： The traditional indexing, end point-controlled method validation system was changed into the novel method validation system with visualization, tracking, and three-dimensional process. The novel system combined establishment with validation of analytical methods, and provided data of high quality. Moreover, this system could effectively record the process of method establishment and validation which was helpful for both information transmission in analysis method transference and evaluation of biopharmaceutical analytical methods.