Fingerprinting Biologics Drugs Using Drop Coat Deposition Confocal Raman (DCDCR) Spectroscopy

ABSTRACT: Counterfeit drugs pose a significant and fast-growing threat to public health and safety. The incident of counterfeit Avastin® in the United States demonstrates the vulnerability of the supply chain even in developed countries. Government health agencies and pharmaceutical manufacturers are finding ways to fight counterfeit and substandard drugs by identifying them from manufacturing, throughout the supply chain, and eventually when they reach the public in the retail pharmacies.  In 2009, Partnership for Safe Medicines (PSI) reported 1,700 counterfeiting incidences worldwide out of which 60 incidences were biologics, compared to only 10 incidences in 2006. With the recent FDA guideline for biosimilar approval and the counterfeit Avastin® reported in the United States, it is becoming increasingly important that pharmaceutical companies find ways to rapidly fingerprint and detect counterfeit biologics.  Counterfeit biologics are, in a way, difficult to detect since they are administered by injection (white powder or clear liquid) and cannot be distinguished by smell, taste, and appearance. This, along with the sizeable cost, makes counterfeiting biologics an attractive illegal business. This presentation demonstrates that Drop Coat Deposition (DCD) technique for the biologics drug product sample, coupled with confocal Raman spectroscopy can be effectively used to fingerprint protein based biologics pharmaceuticals. These spectral fingerprints can be used routinely to screen and detect biologics counterfeits.

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