“The technology could be a game changer for pharmaceuticals,” states the Jan. 12, 2016 Scientific American.com article, “Authentic Drugs Tagged with Plant DNA Could Help Snare Fake Meds. …A new high-tech tactic could help officials detect counterfeit drugs.”
The story points out SigNature® DNA, a botanical-based ink/marker introduced recently by Applied DNA Sciences, Inc. (APDN). The company, which provides DNA-based supply chain, anti-counterfeiting and anti-theft technology, as well as product genotyping and product authentication offerings, developed SigNature DNA into new pharmaceutical-grade and packaging inks suitable for tablet and packaging marking.
Scientific American says, “Each unit of pharmaceutical would contain a unique genetic signature that authorities could detect with basic chemical assessments. The tactic has worked in other industries with complex supply chains such as textiles, and the DNA could be incorporated into the drugs while falling within the strict U.S. [FDA] regulations for how the DNA is safely incorporated. Now all that remains is for pharmaceutical companies to put the solution into action.”
As the online story notes, however, changes to drug formulations could result in complicated and costly changes and clinical trials to satisfy regulatory concerns.
APDN says the inks allow for seamless marking at the point of manufacture, ensuring that original raw materials or ingredients used to produce pharmaceuticals are protected and traceable to point of sale.
The company notes it completed trials with Nissha and KGK partners, showing that unique SigNature DNA marks can be authenticated on the pharmaceutical tablet and packaging materials. APDN says, “The technology satisfies the principles established by FDA Guidelines for inclusion in pharmaceutics and is also applicable to food and cosmetic products.”
APDN can also DNA-mark other elements of a finished product including bulk Active Pharmaceutical Ingredient (API), cellulosic excipients (bulk fillers) that are used in almost all drug tablets and the commercial binders and enteric coatings that hold prescription and over-the-counter drug tablets together. This multi-factor identification enables verification of its authenticity at any point in the supply chain, according to the company.
"The scalability of SigNature DNA for pharmaceuticals solves many supply chain challenges. …Many of our clients that are using SigNature DNA know that forensic tagging and authentication will protect them from the risk of legal liability and product recall while maintaining profitability and market differentiation," says Dr. James A. Hayward, President and CEO, APDN.