设计质量
关键质量属性
工艺验证
工艺工程
生化工程
过程分析技术
质量(理念)
过程(计算)
工艺设计
计算机科学
融合
产品(数学)
生物系统
新产品开发
化学
在制品
工程类
数学
统计
生物
验证和确认
运营管理
业务
过程集成
物理
几何学
语言学
量子力学
营销
哲学
操作系统
作者
Yolande Rouiller,Thomas Solacroup,Véronique Deparis,Marco Barbafieri,Ralf Gleixner,Hervé Broly,Alex Eon‐Duval
标识
DOI:10.1016/j.ejpb.2012.02.018
摘要
The production bioreactor step of an Fc-Fusion protein manufacturing cell culture process was characterized following Quality by Design principles. Using scientific knowledge derived from the literature and process knowledge gathered during development studies and manufacturing to support clinical trials, potential critical and key process parameters with a possible impact on product quality and process performance, respectively, were determined during a risk assessment exercise. The identified process parameters were evaluated using a design of experiment approach. The regression models generated from the data allowed characterizing the impact of the identified process parameters on quality attributes. The main parameters having an impact on product titer were pH and dissolved oxygen, while those having the highest impact on process- and product-related impurities and variants were pH and culture duration. The models derived from characterization studies were used to define the cell culture process design space. The design space limits were set in such a way as to ensure that the drug substance material would consistently have the desired quality.
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