The implementation of CM in biopharmaceutical industry is seriously limited by the deficiencies
of existing process analytical technologies (PATs) used to monitor process and product quality
attributes.
The University of Maryland, Baltimore (UMB) developed a noninvasive analytical technology
based on the water proton NMR signal (wNMR). In this project, the University of Maryland, Baltimore (UMB) and ChromaTan Corporation
(ChromaTan) will develop and implement a novel contact-free real-time in-line process analytical
technology (PAT). This project integrates two technologies for continuous biomanufacturing:
water proton nuclear magnetic resonance (wNMR) developed by UMB, and countercurrent
tangential chromatography (CCTC) developed by ChromaTan.
Industrial flow-wNMR will be integrated with CCTC for continuous
in-line monitoring of actual protein purification processes.
In unstressed and heat-stressed model protein systems, flow-wNMR detected changes in protein concentration (± < 1 mg/mL) and protein aggregate content (± < 1%).
Flow-wNMR detected changes in protein concentration (± < 1 mg/mL) and aggregate content (± < 1%) in the industrial raw material after different steps of mAb purification (AEX eluate, polishing, wash).
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). 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). 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
