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
Process control
Active Immunization Countermeasures
Project status
100% Completed
Industry Need
Currently, there is no contact-free in-line PAT in biomanufacturing and no noninvasive product inspection technology.
Solution
Provide a platform technology (wNMR) for product release inspection and continuous process monitoring as well as at the fill-finish step of manufacturing process.
Outputs/Deliverables
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.
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
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
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