End-to-end process flowsheet modeling for biopharmaceutical production: current state and future potential

IF 8 2区 工程技术 Q1 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Current Opinion in Chemical Engineering Pub Date : 2024-07-26 DOI:10.1016/j.coche.2024.101044
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Abstract

As the biopharmaceutical industry advances to meet the pressures of an expanding product portfolio and global demand, it will continue to face new challenges while concurrently implementing Quality-by-Design principles. At this forefront, flowsheet modeling frameworks will become increasingly important in silico decisional tools during the process design phase. Flowsheet models further enable screening of process configurations, evaluation of technological alternatives, and identification and alleviation of potential bottlenecks within the context of technoeconomic and environmental impact studies. This review summarizes the recent literature on flowsheet methodologies within the monoclonal antibody sector. Key gaps and assumptions, primarily in the simulation of upstream production, present in current flowsheet approaches are examined. Strategies to overcome the identified assumptions are presented, involving the integration of higher resolution unit operation models to improve the accuracy of process assessments by incorporating biologically relevant constraints while maintaining computational feasibility.

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生物制药生产的端到端工艺流程建模:现状与未来潜力
随着生物制药行业的发展,以应对不断扩大的产品组合和全球需求所带来的压力,该行业将继续面临新的挑战,同时还要贯彻质量源于设计的原则。在这一前沿领域,流程表建模框架将在工艺设计阶段成为越来越重要的硅决策工具。在技术经济和环境影响研究的背景下,流程图模型可进一步筛选工艺配置、评估技术替代方案、识别和缓解潜在瓶颈。本综述总结了单克隆抗体领域有关流程表方法的最新文献。对当前流程表方法中存在的主要差距和假设(主要是在模拟上游生产方面)进行了研究。文中还介绍了克服已确定假设的策略,包括整合更高分辨率的单元操作模型,在保持计算可行性的同时纳入生物相关约束条件,从而提高工艺评估的准确性。
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来源期刊
Current Opinion in Chemical Engineering
Current Opinion in Chemical Engineering BIOTECHNOLOGY & APPLIED MICROBIOLOGYENGINE-ENGINEERING, CHEMICAL
CiteScore
12.80
自引率
3.00%
发文量
114
期刊介绍: Current Opinion in Chemical Engineering is devoted to bringing forth short and focused review articles written by experts on current advances in different areas of chemical engineering. Only invited review articles will be published. The goals of each review article in Current Opinion in Chemical Engineering are: 1. To acquaint the reader/researcher with the most important recent papers in the given topic. 2. To provide the reader with the views/opinions of the expert in each topic. The reviews are short (about 2500 words or 5-10 printed pages with figures) and serve as an invaluable source of information for researchers, teachers, professionals and students. The reviews also aim to stimulate exchange of ideas among experts. Themed sections: Each review will focus on particular aspects of one of the following themed sections of chemical engineering: 1. Nanotechnology 2. Energy and environmental engineering 3. Biotechnology and bioprocess engineering 4. Biological engineering (covering tissue engineering, regenerative medicine, drug delivery) 5. Separation engineering (covering membrane technologies, adsorbents, desalination, distillation etc.) 6. Materials engineering (covering biomaterials, inorganic especially ceramic materials, nanostructured materials). 7. Process systems engineering 8. Reaction engineering and catalysis.
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