论文标题
从发现到生产:下一代生物制造的挑战和新方法
From Discovery to Production: Challenges and Novel Methodologies for Next Generation Biomanufacturing
论文作者
论文摘要
具有前所未有的个性化水平的新型药物(例如,个性化癌症护理的基因疗法,对个性化癌症护理的基因疗法,曾经不断发展的疫苗)越来越紧迫的需求造成了显着压力,对制药R&D的传统长时间和制造业所需的长期施加了从设计到新产品的生产。革命已经在行业内使用的技术带来了重要的变化。实际上,从业人员越来越多地从大规模批处理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,这得到了单利设备的最新技术进步的进一步支持。与长期设计过程,低产品可变性(单一的全部)以及高度刚性的系统相比,现代制药公司正在回答以下问题:我们可以将设计和过程控制带到新型生产技术使我们快速建立灵活的生产运行的速度吗? 在本教程中,我们提出了可以支持回答此问题的运营研究领域的关键挑战和潜在解决方案。我们首先提出了针对下一代药物设计的技术挑战和新方法,然后是成功有效地生产它们的过程建模和控制方法。
The increasingly pressing demand of novel drugs (e.g., gene therapies for personalized cancer care, ever evolving vaccines) 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. The revolution has already brought important changes in the technologies used within the industry. 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 from the world of operations research that can support answering such question. We first present technical challenges and novel methods for the design of next generation drugs, followed by the process modeling and control approaches to successfully and efficiently manufacture them.