APDN teams up with Colorcon for pharma authentication

Applied DNA Sciences has formed an alliance with excipient and coating specialist Colorcon for the commercialization of DNA-based taggants.

The new memorandum of understanding is a boost to APDN’s ambitions in the pharma and nutraceutical sectors, a key focus for the company as it tries to boost revenues and convert a wide-ranging programme of pilot studies across multiple industries into repeat commercial orders.

The new deal with Colorcon will combine APDN’s molecular taggant and authentication markers including its SigNature DNA markers with Colorcon’s portfolio of film coating systems, inks and colour dispersions for use in solid oral dosage forms.

“This …is the culmination of a multi-year effort to extend the applicability of our molecular taggant technology to an industry whose participants are moving quickly to address supply chain concerns and comply with federal serialization mandates across multiple continents,” said James Hayward, APDN’s president and CEO.

Those efforts included the appointment of Bob Miglani, who previously served as senior director, external medical affairs for Pfizer, to head APDN’s business development activities in pharma last year. APDN has since started various pilot projects with partners, prepared its facilities and our staff to operate under FDA guidelines and started preparations to file a drug master file (DMF) for its markers.

The DMF – which is scheduled for filing before the end of this year and would cover confidential information on the stability, safety and manufacturing process of APDN’s DNA tags – would allow pharma manufacturers who deploy APDN’s taggant in their products to reference the document in their market applications. While not required for use of the markers in pharma it is thought that it could encourage take-up – provided drugmakers are not side-lined by sticking to serialization mandates.

Commenting on the deal with Colorcon, Miglani said it was “a breakthrough opportunity to help pharmaceutical companies enhance patient safety and reduce risk by using intelligent data and analytics gathered from authentication of the dosage form themselves.”

Just a few weeks back, APDN also announced a partnership with printed coding specialist Videojet on a DNA-encoded ink product that can be used to add an authentication layer to serialized, pack-based safety features.

Meanwhile, it’s not the first time that Colorcon has done a deal with an on-dose authentication specialist, signing up with Adhesive Research (AR) unit ARmark Authentication Technology in 2009, but that division was no longer listed as an AR subsidiary in 2013.