Colorcon launches DNA-based on-dose authentication system

Two years after forging an alliance with Applied DNA Sciences (APDN) on a DNA taggant platform for tablets and capsules, Colorcon has formally launched the technology.

The specialist in pharmaceutical excipients has developed a version of its Opadry film coating technology that incorporates APDN’s SigNature DNA markers and can be used to “significantly reduce the risks associated with counterfeit and falsified medications entering the supply chain.”

In December 2017, Colorcon and APDN announced they were working together on incorporating the taggants into “film coating systems, inks and colour dispersions for use in solid oral dosage forms,” and this is the first commercial offering to come out of that partnership.

According to the two companies:

“This first commercial offering is the culmination of extensive collaboration between Colorcon and ADNAS to help pharmaceutical companies enhance patient safety and reduce risk by using intelligent data and analytics gathered from authentication of the dosage form itself.

“By better understanding the vulnerabilities of a complex global supply chain, drug manufacturers can make informed decisions regarding distribution networks and deploy preventative measures to address counterfeiting and product diversion issues.”

The alliance is one component of APDN’s attempt to break into the pharmaceutical authentication sector to complement its ongoing efforts in other sectors like the cotton industry, where its DNA taggants are used to track fibres from the farm through to the finished product, and the dietary supplement sector.

The launch is also a boost to APDN which has been struggling with revenues that have obstinately failed to go up a gear, cash flow problems and other operational issues that at one point were threatening its Nasdaq listing status.

Alongside its efforts in the authentication sector – which also include a push into tagging products in the emerging cannabis products market – APDN is also trying to move sideways into new applications for its DNA technology, including medicines and diagnostic development.

Meanwhile, for Colorcon the APDN is one of a number of projects it has undertaken to try to develop on-dose authentication options that can protect medicines and complement other efforts focusing on securing their packaging with serialized bar codes and verification technologies.

Earlier this month, the company completed a proof-of-concept pilot study to demonstrate how individual tablets can be tracked through the supply chain using a blockchain-driven digital system provided by PWC and ‘crypto-anchor’ tags supplied by TruTag.