Digitalisation and automation of high-value biomanufacturing

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，获得以蛋白质为基础的药物，如单抗，受到严格限制，因为治疗费用高达每位患者每年35,000美元。这在一定程度上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。负责开发和交付这些药物的生物加工行业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，将业务与监测流程性能的技术相结合，可以带来效率和成本的阶段性变化。拟议工作的目的是开发数字孪生兄弟，这是制造过程的基于计算机的模拟，以及一个界面，很像和APP，用于将其与工艺测量相结合。这项开发将首先专注于成熟的克隆抗体制造工艺，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，使其适应新型蛋白质产品的新制造工艺，这带来了自身的挑战。我们将与工业界密切合作，确保我们的技术实用、方便使用，因此更有可能以负责任的方式使用。我们预计，我们的方法将是使工业加快工艺开发和自动化制造的第一步。

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.