Digitalisation and automation of high-value biomanufacturing

高价值生物制造的数字化和自动化

• 批准号: EP/X024156/1
• 负责人: Cleo Kontoravdi
• 金额: $ 96.17万
• 依托单位: Imperial College London
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=EP%2FX024156%2F1
• 关键词: Digitalisation; automation; value; biomanufacturing

Proteins have been used for the treatment of a variety of life-threatening diseases like cancers and autoimmune disorders for over two decades. Access protein-based drugs, such as monoclonal antibodies, is, however, severely restricted as treatment cost is as high as $35,000 per patient per year. This is due, in part, to the high cost of drug and process development and the high operating cost of the manufacturing process itself. The bioprocessing industry, which is responsible for developing and delivering these drugs, is lagging behind other industries such as automotive, aviation and chemicals manufacture in terms of automation and digitalisation. It is widely thought that the integration of operations with technologies that monitor process performance can introduce a step-change in efficiency and cost-reduction. The purpose of the proposed work is to develop a digital twin, which is a computer-based analogue of the manufacturing process, and an interface, much like and app, for integrating it with measurements from the process. The development will first focus on the mature manufacturing process of monoclonal antibodies to finetune the models and their integration with sensing technologies. We will then proceed to adapt our work to a new manufacturing process of novel protein products, which presents its own challenges. We will work closely with industry to ensure that our technology is practical and user-friendly and, therefore, more likely to be used in a responsible way. We envisage that our approach will be a first step towards enabling industry to expedite process development and automate manufacturing.

二十多年来，蛋白质一直被用于治疗各种危及生命的疾病，如癌症和自身免疫性疾病。然而，单克隆抗体等基于蛋白质的药物的获取受到严重限制，因为每位患者每年的治疗费用高达3.5万美元。这部分是由于药物和工艺开发的高成本以及制造工艺本身的高运营成本。生物加工行业负责开发和交付这些药物，在自动化和数字化方面落后于汽车、航空和化学品制造等其他行业。人们普遍认为，将操作与监控过程性能的技术相结合，可以在效率和成本降低方面带来一个阶段性的变化。拟议工作的目的是开发一个数字双胞胎，这是一个基于计算机的制造过程模拟，以及一个接口，很像一个应用程序，用于将其与过程中的测量相集成。开发将首先集中在成熟的单克隆抗体制造工艺上，以微调模型及其与传感技术的集成。然后，我们将继续调整我们的工作，以适应新的蛋白质产品的新制造工艺，这提出了自己的挑战。我们将与业界紧密合作，确保我们的技术实用且易于使用，从而更有可能以负责任的方式使用。我们设想我们的方法将是使行业加快流程开发和自动化制造的第一步。