Currently, there is no contact-free in-line PAT in biomanufacturing and no noninvasive product inspection technology.
Provide a platform technology (wNMR) for product release inspection and continuous process monitoring as well as at the fill-finish step of manufacturing process.
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.
By implementing noninvasive water proton NMR (wNMR)-based Process Analytical Technology (PAT), an organization could reduce quality control and manufacturing costs associated with aluminum-adjuvanted vaccines by eliminating invasive sampling and minimizing fill-finish errors, enabling real-time in-line monitoring and improved vaccine safety and efficacy, thereby creating a platform for continuous manufacturing and enhancing public confidence in vaccines.
Water proton NMR (wNMR) noninvasively quantified the changes in antigen-adjuvant complexes under gravitational, flow and freeze/thaw stresses.
wNMR determined sedimentation volume ratio (SVR) of antigen-adjuvant complexes and sedimentation rate of antigen-adjuvant complexes, important parameters for vaccine formulation and stability.
wNMR results were validated by industry partners using conventional analytical techniques.
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
Yu, Y. B., Briggs, K. T., & Taraban, M. B. (2023). Preventive Pharmacovigilance: timely and precise prevention of adverse events through person-level patient screening and dose-level product surveillance. Pharmaceutical Research, 40(9), 2103-2106. https://doi.org/10.1007/s11095-023-03548-3
Noninvasive PAT for Aluminum-adjuvanted Vaccines (PC2.2-077), NIIMBL Member Forum, Virtual, January 27, 2022.
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University of Maryland Baltimore
Merck Sharp & Dohme LLC
Pfizer, Inc.
