设计质量
过程(计算)
计算机科学
关键质量属性
工艺工程
稳健性(进化)
过程建模
过程开发
过程分析技术
表征(材料科学)
工艺设计
生化工程
工艺优化
在制品
化学
纳米技术
工程类
材料科学
过程集成
运营管理
环境工程
粒径
物理化学
操作系统
基因
生物化学
作者
Yan-Na Sun,Wu-Wei Chen,Shan‐Jing Yao,Dong‐Qiang Lin
标识
DOI:10.1016/j.chroma.2023.464302
摘要
Continuous manufacturing in monoclonal antibody production has generated increased interest due to its consistent quality, high productivity, high equipment utilization, and low cost. One of the major challenges in realizing continuous biological manufacturing lies in implementing continuous chromatography. Given the complex operation mode and various operation parameters, it is challenging to develop a continuous process. Due to the process parameters being mainly determined by the breakthrough curves and elution behaviors, chromatographic modeling has gradually been used to assist in process development and characterization. Model-assisted approaches could realize multi-parameter interaction investigation and multi-objective optimization by integrating continuous process models. These approaches could reduce time and resource consumption while achieving a comprehensive and systematic understanding of the process. This paper reviews the application of modeling tools in continuous chromatography process development, characterization and design. Model-assisted process development approaches for continuous capture and polishing steps are introduced and summarized. The challenges and potential of model-assisted process characterization are discussed, emphasizing the need for further research on the design space determination strategy and parameter robustness analysis method. Additionally, some model applications for process design were highlighted to promote the establishment of the process optimization and process simulation platform.
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