Noninvasive Detection of Counterfeit and Substandard Vaccines and Biotherapeutics

This project aims to develop a simple, fast, inexpensive, and noninvasive technology and a testing facility to detect counterfeit and substandard vaccines.
Categories
Process control
Active Immunization Countermeasures

Industry Need

  • Counterfeit detection technology faces two fundamental limitations: 
  • Invasive analysis, which restricts inspection to a few vials per batch/shipment 
  • Point-of-care detection by end users is not possible; detection is performed by highly trained personnel in labs 
  • Other less fundamental but practical limitations include the cost and lengthiness of the detection. 


Solution

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.

Outputs/Deliverables

  • New temperature-controlled benchtop NMR system with robotic control has been manufactured and installed​
  • Novel noninvasive technology for detection of counterfeit and substandard vaccines and biotherapeutics has been developed​
  • Complex and simple counterfeits of vaccines and biotherapeutics were detected​
  • Quality and substandard vaccines and biotherapeutics were detected​
  • Multivariate wNMR fingerprinting approach has been explored successfully

Impacts

This novel technology will provide a simple, fast, inexpensive, and non-invasive way to detect counterfeit and substandard vaccines.

Publications

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.

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

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

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Project Lead

University of Maryland Baltimore

University of Maryland Baltimore