I-Corps Team: Ultra Dielectric Probes

在线过程分析技术（PAT）是使生物制药公司能够显着提高药物质量和生产力所必需的。目前生产工厂和实验室的现场监测仍然主要基于测量温度、pH值、溶解氧、压力、气流和液体流量。这些参数没有给出关于细胞活力、周期、大小、自噬和凋亡的信息，这些信息是指示生物过程的再现性的度量。FDA建议，近红外、中红外、拉曼光谱、荧光和成像以及质谱等关键PAT技术都在积极开发中，但存在这样或那样的局限性，如灵敏度有限、难以使用和成本高。介电谱也被研究作为一种有前途的方法，但还不适合PAT由于有限的灵敏度和信息contents.This项目涉及一种新的射频（RF）干涉仪技术的在线过程分析技术（PAT）仪器的发展。所获得的射频（RF）探头利用新的干扰过程，以提高灵敏度，同时应用新的调谐机制，以覆盖广泛的频率范围和调谐灵敏度，为强大的系统操作。预计RF探针将具有前所未有的灵敏度和稳健性，以无标记和非侵入性方式分析细胞活力，自噬，凋亡和大小。这些单元格属性中的许多属性在其他PAT方法中不可用。预计电子方法将能够大规模生产低成本和易于使用的PAT仪器。

On-line Process Analytical Technology (PAT) is needed in enabling biopharmaceutical companies to significantly improve drug quality and productivity. Current in-situ monitoring in production plants and laboratories is still mainly based on measuring temperature, pH, dissolved oxygen, pressure, airflow, and liquid flow. These parameters do not give information on cell viability, cycle, size, autophagy and apoptosis that are metrics to indicate reproducibility of the bioprocess. FDA suggested key PAT technologies such as near-infrared, mid-infrared, Raman spectroscopy, fluorescence and imaging, and mass spectroscopy, are all under active development, but with limitations of one kind or another, such as limited sensitivity, difficult to use, and high cost. Dielectric spectroscopy is also studied as a promising approach, but not yet appropriate for PAT due to limited sensitivity and information contents.This project involves a novel radio frequency (RF) interferometer technique for On-line Process Analytical Technology (PAT) instrument development. The obtained radio frequency (RF) probes exploit novel interference processes to enhance sensitivity while applying novel tuning mechanisms to cover broad frequency ranges and tune sensitivity for robust system operations. The RF probes are expected to have unprecedented sensitivity and robustness to analyze cell viability, autophagy, apoptosis, and size in a label-free and non-invasive manner. Many of these cell properties are not available in other PAT methods. The electronic approach is expected to enable mass produced low-cost and easy-to-use PAT instruments.