Michael Hogan, PhD, Vice President, Life Sciences at Applied DNA Sciences, explains how the advent of DNA-marking technology provides a potential weapon against rampant counterfeiting of pharmaceuticals and cosmetics.
All living things have DNA that identifies them uniquely. For instance, the DNA in a human being can be used by a forensics lab, with complete certainty, to establish identity relative to all other humans. This process works because, at its core, the DNA in any organism acts as a molecular barcode that can be read, much as a conventional barcode can be read by standard technology.
With breakthroughs in nanotechnology, forensic science and material sciences, it has now become possible to formulate DNA into materials that are non-biological: to generate DNA-containing plastics, fabrics, inks, pharmaceutical coatings, oils, emulsifiers and detergents. The advent of this technology is extremely important today as a potential weapon against rampant counterfeiting in two wide-reaching areas: pharmaceuticals and cosmetics.
The pharmaceutical supply chain has been contaminated by counterfeiting and by diversion of legitimate products. Both types of contamination have been magnified by growth in the increase in the number of on-line pharmacies, global and complex supply chains and high margins sought by counterfeiters. The net result has been a loss of brand credibility, a loss of faith in drug regulatory authorities’ review processes, as well as an inability to protect patients in the new electronic marketplace. Perhaps most importantly, the new and greatest risk is the substantial harm incurred by patients who buy “fake” or otherwise substandard medication in these markets. An estimated 1 in 10 medical products circulating in low- and middle-income countries is either substandard or falsified, according to the World Health Organization.1
The newly developed fields of DNA barcoding and DNA-specific formulation chemistry offer a solution. Applied DNA Sciences is currently collaborating with two major pharmaceutical dosage component manufactures in the areas of excipients (inks, film coatings, colourants) and hard-capsule shells. The goal of these collaborations is to expand DNA barcoding to become the new industry standard for control and authentication in the solid oral dosage form-based pharmaceutical supply chain. Similar considerations hold true for the application of DNA barcode technology to cosmetics supply chain control.
How the technology works
DNA barcodes (also known in the pharmaceutical industry as a physical, chemical identifier or “PCID”) are composed of short, unmodified double-stranded DNA molecules generated biochemically. Although synthesized from standard DNA building blocks, the PCIDs have been designed to be a product identifier, only, without any biological function. By fabricating DNA as very small fragments, the DNA-based PCID becomes highly stable with respect to extreme heat, UV light and dryness. DNA barcodes have the capacity to convey a large amount of information. As a result, a DNA-based PCID permits the tracking of a product through the supply chain, employing only femtogram amounts (10-15 grams) of DNA per identifier.