Applied DNA Sciences introduces SigNature DNA in new pharmaceutical-grade and packaging inks

SigNature DNA offers authenticity and traceability for pharmaceutical global supply chains.

Powered by unique botanical-based SigNature DNA, these inks allow for seamless marking at the point-of-manufacture, ensuring that original raw materials or ingredients used to produce pharmaceuticals are fully protected and traceable to point-of-sale. APDN has completed trials with Nissha and KGK partners, proving that unique SigNature DNA marks can be authenticated on the pharmaceutical tablet and packaging materials. The technology satisfies the principles established by FDA Guidelines for inclusion in pharmaceutics and is equally applicable to food and cosmetic products.

APDN can also DNA-mark other elements of a finished product including bulk APIs, cellulosic excipients (bulk fillers) that are used in almost all drug tablets and the commercial binders and enteric coatings that hold prescription and OTC drug tablets together. This unique, multi-factor identification enables verification of its authenticity at any point in the supply chain. Countries around the world have accelerated their adoption of drug quality regulations in the effort to ensure product integrity and protect patient safety. Regulations covering more than 75% of the global medicine supply by 2018 include packaging standards from Japan's Ministry of Health, Labor and Welfare and directives from the FDA's Title II of the Drug Supply Chain Security Act. Companies acting now can benefit from SigNature DNA solutions that forensically backstop pharmaceutical traceability.

"The scalability of SigNature DNA for pharmaceuticals solves many supply chain challenges as recently highlighted in Scientific American. 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," stated Dr James A. Hayward, President and CEO, APDN.