Advanced Technologies and Platforms for Separation and Characterization of Biological Analytes

点击翻译按钮获取中文摘要

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.