I-Corps Team: Ultra Dielectric Probes

Clemson University, Clemson SC

Investigators

Abstract

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.