Performance Period: 3/1/2018 to 10/31/2019
This work develops a contact-free real-time in-line process analytical technology (PAT) for biomanufacturing. The technology, flow-wNMR, is based on the nuclear magnetic resonance signal of water. Because water is the solvent in all biomanufacturing processes, flow-wNMR has wide applicability. Flow-wNMR has no contact with the process stream, therefore probe fouling, a fundamental limitation of existing in-line PATs, is completely eliminated. The focus of this project is to integrate flow-wNMR with a continuous protein purification system — countercurrent tangential chromatography. The simplicity, flexibility, affordability and sturdiness of flow-wNMR make it easily adoptable to various floor conditions in biomanufacturing plants.
Reduced time for drug substance release
In-line measurement of critical quality attributes thereby enabling real time process control
Taraban, M. B., Briggs, K. T., & Yu, Y. B. (2020). Magnetic Resonance Relaxometry for Determination of Protein Concentration and Aggregation. Current Protocols in Protein Science, 99(1), e102. https://doi.org/10.1002/cpps.102
Briggs, K. T., Taraban, M. B., Wang, W., & Yu, Y. B. (2019). Nondestructive Quantitative Inspection of Drug Products Using Benchtop NMR Relaxometry-the Case of NovoMix(R) 30. AAPS PharmSciTech, 20(5), 189–0. https://doi.org/10.1208/s12249-019-1405-0
Taraban, M. B., Briggs, K. T., Merkel, P., & Yu, Y. B. (2019). Flow Water Proton NMR: In-Line Process Analytical Technology for Continuous Biomanufacturing. Analytical Chemistry, 91(21), 13538–13546. https://doi.org/10.1021/acs.analchem.9b02622
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University of Maryland Baltimore
ChromaTan Corporation