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PAT concepts for chromatography: Real-time monitoring, real-time control, and cause of error diagnostics

机译:色谱法的PAT概念:实时监控,实时控制和错误诊断原因

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In the recent years, the growing competition in the biopharmaceutical industry due to biosimilars combined with market fluctuations and increasing product pipelines have given rise to the evaluation of continuous processing. Advantages include smaller e□uipment that may be disposable, an overall process intensification as well as steady-state operation. As variability should be managed by the continuous process itself to insure a consistent product □uality, the development of advanced Process Analytical Technology (PAT) concepts is one crucial aspect for the implementation of continuous processing.
机译:近年来,由于生物仿制药,市场波动以及不断增加的产品线,生物制药行业的竞争日趋激烈,因此对连续加工进行了评估。优点包括较小的设备(可以一次性使用),整个过程的增强以及稳态操作。由于应由连续过程本身来管理可变性以确保产品质量的一致性,因此先进过程分析技术(PAT)概念的开发是实现连续过程的关键方面。

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