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Noninvasive PAT for Aluminum-adjuvanted Vaccines

This project will develop a real-time, non-invasive process analytical technology for biopharmaceutical products using nuclear magnetic relaxation of water. wNMR is a true platform technology for biomanufacturing.
Categories
Proteins/ Antibodies
Vaccines
Process control
Project status
100% Completed

Solution

Performance Period: 2/3/2020 to 12/31/2021

This project will develop a real-time, non-invasive process analytical technology for biopharmaceutical products using nuclear magnetic relaxation of water. Because water is the solvent for all bioprocessing operations and all biologic products, wNMR is a true platform technology for biomanufacturing, both for process monitoring and product inspection. This technology will be used to characterize the aluminum-antigen adsorption process and evaluate the stability of antigen-aluminum complex under stress. This non-invasive, real-time approach limits contamination and enables uninterrupted manufacturing operation reducing time and cost. 

Impacts

Monitor adsorption of aluminum adjuvants to antigen in real-time and noninvasively using non-flow wNMR.

Measure kinetics of antigen-alum adsorption reaction with kon and koff.

Publications

Taraban, M. B., Briggs, K. T., Yu, Y. B., Jones, M. T., Rosner, L., Bhambhani, A., Williams, D. M., Farrell, C., Reibarkh, M., & Su, Y. (2023). Assessing Antigen-Adjuvant Complex Stability Against Physical Stresses By wNMR. Pharmaceutical Research, 40(6), 1435–1446. https://doi.org/10.1007/s11095-022-03437-1

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Project Lead

University of Maryland Baltimore

University of Maryland Baltimore

Participating Organizations

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

Pfizer, Inc.

Pfizer, Inc.