Novel analytical instrumentation and methods to improve prediction of biopharmaceutical aggregation

生物制药，包括治疗性蛋白质和单抗疗法，现在很重要，预计将成为进入市场的新药的越来越重要的来源。虽然这些药物可以显著提高生活质量，但与小分子药物疗法相比，它们的生产成本很高。因此，例如，NHS是否负担得起一种新的生物制药产品，或者现有产品的一种新形式是否具有竞争力，将越来越取决于制造成本和产品是否易于使用。该项目的目标之一是帮助这一快速扩张和成熟的行业提供更高效的流程，从而产生更好的产品和患者依从性；另一个目标是能够预测更快到达患者的路径。该项目将深入探索一种新的获奖技术的有用性，以帮助生物制药制造商开发蛋白质药物。在这个项目中开发的新技术将确定组成药物的分子是否粘在一起，如果是的话，将允许精确测量效果。这种粘在一起或聚集在一起可能会导致药物失效，在最糟糕的情况下会导致身体产生不良反应。除了在实验室中使用新的UV区域成像技术外，该项目还旨在将该技术转移到工厂，使工艺操作员能够增强生物制药制造中的净化阶段。这项技术将与现有的和其他新出现的检测聚集的方法进行比较和基准。最终，这项技术在工业上的应用应该会导致更多更好的生物制药产品更快地到达患者手中。

Biopharmaceuticals, including therapeutic proteins and monoclonal antibody therapies, are now important and are projected to become an increasingly important source of new drugs reaching the market-place. Whilst the quality of life enhancement of these drugs can be substantial, they are expensive to produce relative to small molecule drug therapeutics. Thus, whether a new biopharmaceutical product is affordable by the NHS, for example, or whether a new form of an existing product is competitive, will increasingly depend on the cost of manufacture and whether the product is easy to use. One of the aims in this project is to help enable this rapidly expanding and maturing sector to deliver more efficient processes, leading to better products and patient compliance; another aim is the ability to predict faster to patient pathways. This project will thoroughly explore the usefulness of a novel award-winning technology to help biopharmaceutical manufacturers develop protein medicines. The novel technology developed in this project will determine whether the molecules that make up the medicine are sticking together, and if so will allow a precise measure of the effect. This sticking together or aggregation can cause the medicine to lose efficacy or in the worst case cause the body to react adversely. As well as using the novel UV area imaging technology in the laboratory, the project also aims to transfer the technology to the factory to allow the process operator to enhance the purification stage in manufacture of biopharmaceuticals. The technology will be compared and benchmarked against existing and other newly emerging methods of detecting aggregation. Ultimately the application of this technology when in industrial use should lead to more and better biopharmaceutical products reaching the patient sooner.