The University of Maryland, Baltimore, aimed to overcome the fundamental limitations of current technologies by creating novel technology to detect counterfeit and substandard medicines.
This technology has the potential to enable end users, after minimal training, to conduct detection on every vial right before injection. The end-users include healthcare providers and even patients. This transformation is analogous to how cell phones transformed information recording and propagation; almost everyone can do it because the technology is simple, fast, and affordable.
This novel technology will provide a simple, fast, inexpensive, and non-invasive way to detect counterfeit and substandard vaccines.
Integrating noninvasive water proton NMR (wNMR) technology enables rapid, automated analysis of sealed dosage units, eliminating destructive testing and reducing material and operational costs. Validated multivariate fingerprinting reliably distinguishes authentic drugs from counterfeit or substandard products, accelerating quality control and improving supply chain efficiency.
A validated multivariate analytical approach has been developed utilizing noninvasive water proton NMR (wNMR) technology. wNMR generates distinctive individual fingerprints of drug products, enabling differentiation of counterfeit or substandard dosage units. With this innovative approach, identification of falsified or suboptimal quality dosage units and discrimination from authentic units become easily achievable. This novel technology holds particular advantages for least developed countries with limited access to advanced analytical technologies. In these regions, it offers the opportunity to overcome the challenges posed by resource constraints and provide effective detection of counterfeit and substandard drugs, thereby safeguarding public health and well-being.
In contrast to current practices, this innovative technology has the capability to analyze the contents of sealed vials and syringes without requiring them to be opened. Consequently, even after inspection, the vials and syringes that pass the assessment can still be safely utilized by patients, as the integrity of their contents remains uncompromised. The analysis is not only rapid but also has the potential for automation and high-throughput capabilities. This could ensure efficient quality control of every vial and syringe, contributing to enhanced drug safety and efficacy. The combination of speed and automation enables reliable product assessment, ultimately improving patient care and reinforcing confidence in the pharmaceutical products being administered.
Ophir, Y.,Wong, J., Haddad, K., Huuskonen, A., Karmaker, A., Gore V., Jung, S., Oloumi, A., Liu, Y., Fu, J., Zhang, L., Huang, P., Minami, S., Garimella, S., Thyagatur, A., Zaini, P., Vitikainen, M., Tchelet, R., Valbuena, N., Fuerst, T., Korkmaz, E., Falo Jr, L., Balmert, S., Mahendiratta, S., Emalfarb, M., Shah, P., Siegel, J., Danekar, A., Chen, X., Lebrilla, C., Faller, R., Saloheimo, M., McDonald, K., & Nandi, S. (2025) Expression and Characterization of SARS-CoV-2 Spike Protein in Thermothelomyces heterothallica C1. BioRxIV https://doi.org/10.1101/2025.05.01.651343
Taraban, M., Briggs, K., Karki, P., & Yu.B. (2025). Advancing Pharmaceutical Security: Noninvasive Detection of Falsified Vaccines and Drugs Using wNMR. Pharmaceutical Research https://doi.org/10.1007/s11095-025-03880-w
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. Pharm Res 40, 2103–2106. https://doi.org/10.1007/s11095-023-03548-3
Gazaille, B., Taraban, M., Interview for BioProcess International, Water-Proton Nuclear Magnetic Resonance Spectroscopy, Emerging Applications for Vaccine Quality Assessment, BioProcess Int. 2023, 21(1–2), 12-16. https://bioprocessintl.com/manufacturing/vaccines/water-proton-nuclear-magnetic-resonance-spectroscopy-emerging-applications-for-vaccine-quality-assessment/
Taraban, M. B.; Briggs, K. T.; Yu, Y. B., Presenter, ARP-25: Noninvasive Detection of Counterfeit and Substandard Vaccines and Biotherapeutics, 2022 NIIMBL National Meeting, Washington, DC, July 26-28, 2022.
Taraban, M., Presenter, ARP-25 Noninvasive detection of counterfeit and substandard vaccines and biotherapeutics, NIIMBL National Meeting, Washington, D.C., July 28, 2022.
Taraban, M. B., Presenter, Benchtop NMR—Biomanufacturing Applications, BioProcess International and Cell & Gene Therapy Manufacturing and Commercialization, Boston Biotech Week, Boston, MA, September 27-30, 2022.
Taraban, M. B., Presenter, Water Proton Nuclear Magnetic Resonance for Vaccine and Gene Therapy Product Characterizations, Practical Applications of NMR in Industry Conference, San Diego, October 16-19, 2022.
Yu, Y. B., Presenter, Noninvasive detection of counterfeit and substandard vaccines and biotherapeutics using wNMR, FDA webinar, August 8, 2022. https://fda.zoomgov.com/rec/share/fei-0ZZ5R0WmMh4TxZISo–dlMWNPE6k5W_4DAaKRqTpJ22zDGWnnm3liO3gDDUR.k8AcfQ-yRfzKtyNa. Access code: G@0k2E+r
Yu, Y. B., Presenter, wNMR for Pharmaceutical Manufacturing and Preventive Pharmacovigilance, FDA webinar, March 8, 2023.
Yu, Y. B., Presenter, wNMR for Pharmaceutical Manufacturing and Preventive Pharmacovigilance, School of Pharmacy, University of Utah, March 13, 2023.
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University of Maryland Baltimore
