From Discovery to Production: Challenges and Novel Methodologies for Next Generation Biomanufacturing
From Discovery to Production: Challenges and Novel Methodologies for Next Generation Biomanufacturing
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DOI：
10.1109/wsc57314.2022.10015464
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发表时间：
2022-05
期刊：
影响因子：
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通讯作者：
Wei-yang Xie;Giulia Pedrielli
中科院分区：
文献类型：
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作者：
Wei-yang Xie;Giulia Pedrielli
对新型生物药物的需求日益迫切（例如，基因疗法）具有前所未有的个性化水平，对制药研发和制造从设计到生产新产品所需的传统长时间施加了巨大压力。事实上，从业者越来越多地从大规模批量生产的经典范式转向具有灵活和模块化设计的连续生物制造，这进一步得到了一次性设备最近技术进步的支持。与漫长的设计流程、低产品可变性（一刀切）和高度刚性的系统相比，现代制药企业正在回答这样一个问题：我们能否将设计和过程控制提高到新生产技术所提供的速度，从而快速建立灵活的生产运行？在本教程中，我们提出了关键的挑战和潜在的解决方案，在新的生物过程建模和控制策略的集成设计和制造的下一代生物药物。
The increasingly pressing demand of novel bio-drugs (e.g., gene therapies) with unprecedented levels of personalization, has put a remarkable pressure on the traditionally long time required by the pharma R&D and manufacturing to go from design to production of new products. In fact, practitioners are increasingly moving away from the classical paradigm of large-scale batch production to continuous biomanufacturing with flexible and modular design, which is further supported by the recent technology advance in single-use equipment. In contrast to long design processes, low product variability (one-fits-all), and highly rigid systems, modern pharma players are answering the question: can we bring design and process control up to the speed that novel production technologies give us to quickly set up a flexible production run? In this tutorial, we present key challenges and potential solutions in terms of new bioprocess modeling and control strategies for integrated design and manufacturing of next generation bio-drugs.