Advanced Technologies and Platforms for Separation and Characterization of Biological Analytes

生物技术产业在生物反应器中生产高浓度蛋白质疗法方面已经变得非常熟练。因此，与制造这些救命药物相关的主要成本和挑战比以往任何时候都更多地存在于安全和经济地净化它们所需的过程中。现在需要现有纯化技术的重大进步，以及全新的纯化概念，以使产品回收能力与细胞培养技术的巨大进步保持一致。制造成本必须降低到有助于降低公认的医疗保健成本上升的水平，并使现在每年价值4000亿美元的行业的产品与《平价医疗法案》保持一致。我的NSERC DG支持的研究项目的目标是创建一些这些必要的能力，然后将每个能力发展到一个被工业实际采用的水平。工业色谱柱的新包装将被创建，允许更高的吞吐量，同时保持高产量和产品纯度，使色谱法在生产规模分离生物药物的首选方法。一种全新的色谱模式将被开发出来，它可能允许工业界处理历史上很难纯化的治疗性蛋白质。将创造新技术，使工业界能够更密切地监测和控制正在生产的药品的质量。最后，将建立一条新的管道，为孤儿药（用于治疗罕见但使人衰弱的疾病的生物制剂）的有效色谱纯化提供快速发展。因此，该项目有望在用于制造救生生物疗法的仪器和方法方面提供重要的基础和操作进展。

The Biotechnology Industry has become incredibly skilled at producing protein therapeutics to high concentrations in biological reactors. As a result, more than ever the primary cost and challenges associated with manufacturing these life-saving drugs reside in the processes required to purify them safely and economically. Major advances in existing purification technologies, as well as entirely new purification concepts, are needed right now to align product recovery capabilities with the tremendous advances seen in cell-culture technology. Manufacturing costs must be reduced to levels that help abate the recognized rising costs of healthcare and bring the products of what is now a $400 billion US per annum industry in tune with the Affordable Care Act. The objective of my NSERC DG supported research program is to create a number of these required capabilities and then develop each to a level where its adoption by industry is actually realized. New packing for industrial chromatography columns will be created that allows for much higher throughputs while preserving the high yields and product purities that make chromatography the preferred method for isolating biologic drugs at manufacturing scales. An entirely new mode of chromatography will be developed that may allow industry to process therapeutic proteins that have historically been very difficult to purify. New technology will be created to enable industry to more closely monitor and control the quality of the drug product as it is being manufactured. And finally, a new pipeline that provides for rapid development of effective chromatographic purification of orphan drugs - biologics used to treat rare but debilitating diseases - will be established. The program is therefore expected to provide important fundamental and operational advances in the instrumentation and methods used to manufacture life-saving biologic therapeutics.