Advancing Pharmaceutical Security: Noninvasive Detection of Falsified Vaccines and Drugs Using wNMR.

Objective: To develop and apply noninvasive analytical technologies to detect falsified vaccines and drugs.

Methods: Univariate and multivariate methods, based on the water nuclear magnetic resonance (wNMR) technology, was explored as a tool for noninvasive detection of simple and sophisticated falsified vaccines, biotherapeutics and anesthetics. All wNMR measurements were done noninvasively on sealed vials, prefilled syringes, and injection pens. Saline USP served as a simple falsified drug product while highly similar vaccines and drugs (brand vs. generics/biosimilars) served as each other's sophisticated falsified drug products for technology development and testing.

Results: Simple falsified drug products, represented by USP saline, can be differentiated from authentic vaccines and drugs by univariate wNMR. Sophisticated falsified drug products, represented by highly similar products, can be differentiated from authentic ones by univariate wNMR in some cases and by multivariate wNMR in all cases, attesting to the high discriminating power of wNMR in product authentication. The multivariate methods generate 2D and 3D data arrays that may serve as fingerprints of vaccines and drugs.

Conclusions: A suite of noninvasive analytical methods, based on the wNMR technology, have been developed to detect falsified vaccines and drugs. wNMR analyzes vaccines and drugs in their primary containers without opening and uses benchtop instruments with no wet lab operations and no reagents. wNMR detection of falsified drug products may be implemented in low-resource settings for enhanced pharmaceutical security and preventive pharmacovigilance.