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).
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
Yu, B., General Applications of Water Proton NMR as a Noninvasive Analytical Tool, Bristol-Myers Squibb, New Brunswick, NJ, November 13, 2019.
Yu, B., 1H2O NMR for in situ Detection of Protein Aggregation, 18th Annual PepTalk, San Diego, CA, January 18, 2019.
Yu, B., 1H2O NMR: Noninvasive Analytic for Biopharmaceutical Manufacturing and Quality Control, University of Milan, Milan, Italy, June 21, 2018.
Yu, B., 1H2O NMR: Noninvasive Analytic for Biopharmaceutical Manufacturing and Quality Control, University of Brescia, Brescia, Italy, June 26, 2018.
Yu, B., 1H2O NMR: Noninvasive Analytic for Biopharmaceutical Manufacturing and Quality Control, Lonza, Basel, Switzerland, June 29, 2018.
Yu, B., Improving Drug Product QC through Noninvasive Analytics: 1H2O NMR, 18th European Congress on Biotechnology, Geneva, Switzerland, July 4, 2018.
Yu, B., 1H2O NMR: Noninvasive Analytic for Biopharmaceutical Manufacturing and Quality Control, 2018 Summer BITC Summer Symposium, Newark, DE, July 25, 2018.
Yu, B., 1H2O NMR for Noninvasive Analysis of Biologics and other Complex Drugs, 10th Biotherapeutic Analytical Summit, Alexandria, VA, March 6, 2019.
Yu, B., Nondestructive Analysis of Biologics and other Complex Drugs, Institute for Bioscience and Biotechnology Research, Rockville, MD, March 11, 2019.
Yu, B., Nondestructive Analytics for Biologics and Continuous Biomanufacturing, Bristol-Myers Squibb, Hopewell, NJ, November 12, 2019.
Yu, B., Flow 1H2O Proton NMR as Contact-free Real-time PAT for Continuous Biomanufacturing, NIIMBL 2019 National Meeting, Washington, DC, June 28, 2019.
Yu, B., Nondestructive Analytics for Drug Product Inspection, Bristol-Myers Squibb, Hopewell, NJ, November 12, 2019.
Yu, B., Nondestructive Analytics for Drug Product Inspection, Bristol-Myers Squibb, Hopewell, NJ, November 12, 2019.
Yu, B., Taraban, M., & Briggs, K., Nondestructive Inspection of Complex Drug Products, 2018 Military Health System Research Symposium, Kissimmee, FL, August 22, 2018.
Yu, B., Taraban, M., Briggs, K., & Fox, C., Noninvasive Analytics for Complex Drugs, International Alliance for Biological Standardization, Geneva, Switzerland, October 16, 2018.
Yu, B., Taraban, M., Briggs, K., & Fox, C., Noninvasive Analytics for Complex Drugs, International Alliance for Biological Standardization, Geneva, Switzerland, October 16, 2018.
Taraban, M., Briggs, K., & Yu, B., Water Flow-NMR—A Prospective Contact-Free Analytical Tool for Continuous Biomanufacturing, Practical Applications of NMR in Industry Conference (PANIC) 2019, Hilton Head Island, SC, March 3, 2019.
Taraban, M., Briggs, K., Yu, B., Fedorenko, D., & Shinkazh, O., QSP 1.09: Flow 1H2O Proton NMR as Contact-free Real-time PAT for Continuous Biomanufacturing, NIIMBL National Meeting, Washington, DC, June 26, 2019.
Taraban, M., Briggs, K., Yu, B., Fedorenko, D., & Shinkazh, O., QSP 1.09: Flow 1H2O Proton NMR as Contact-free Real-time PAT for Continuous Biomanufacturing, NIIMBL National Meeting, Washington, DC, June 26, 2019.
Briggs, K., Yu, B., & Taraban, M., Low-Field NMR in Nondestructive Quantitative Inspection of Drug Products, Biophysical Society Annual Meeting, Baltimore, MD, March 2, 2019.
Briggs, K., Yu, B., & Taraban, M., Low-Field NMR in Nondestructive Quantitative Inspection of Drug Products, Biophysical Society Annual Meeting, Baltimore, MD, March 2, 2019.
Taraban, M., Briggs, K., Yu, B., Fedorenko, D., & Shinkazh, O., QSP 1.09: Flow 1H2O Proton NMR as Contact-free Real-time PAT for Continuous Biomanufacturing, NIIMBL National Meeting, Washington, DC, May 16, 2018.
Taraban, M., Briggs, K., Fox, C., & Yu, B., Noninvasive Analytics for Complex Drugs, Gordon Research Conference on Biotherapeutics and Vaccine Development, Galveston, TX, January 10, 2019.
Yu, B., Flow Water Proton NMR as Contact-free Real-time PAT for Continuous Biomanufacturing, Biopharmaceutical Manufacturing 2018 National Meeting, Washington, DC, May 17, 2018.
Yu, B., Briggs, K., & Taraban, M., Probing Solute Organization by Water Proton NMR, Experimental NMR Conference (ENC) 2018, Orlando, FL, April 30, 2018.
Yu, B., Flow Water Proton NMR as Contact-free Real-time PAT for Continuous Biomanufacturing, NIIMBL Member Forum, Virtual, April 25, 2019.
Reduced time for drug substance release
In-line measurement of critical quality attributes thereby enabling real time process control
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University of Maryland Baltimore
ChromaTan Corporation
