APDN takes another step into pharma with traceability alliance

Supply chain security firm Applied DNA Sciences has signed a memorandum of understanding with pharmaceutical capsule and tablet manufacturer ACG for enhanced traceability and authentication of ACG’s capsule products.

The MoU, which is expected to be followed by a definitive agreement, will see Bengaluru-based ACG use APDN’s SigNature molecular tagging and authentication technologies to develop molecularly tagged empty hard-shell capsules to improve the product’s traceability for ACG’s pharma and nutraceutical customers.

The alliance follows APDN’s push into the pharma and nutraceutical sectors, and comes at a time when the company has yet to make the breakthrough it wants in these new industrial sectors to build sales momentum. In first quarter finances released earlier this month it reported a loss of $3.2m or 12 cents per share.  

The new alliance however is being billed as a positive concerted move to address counterfeits in the pharmaceutical supply chain.

According to ACG, the move will improve the integrity of its customers’ supply chains and aid any investigations into suspected counterfeit medicines, both of which will enhance patient and regulator confidence in the supply chain. 

“With the increasing threat of counterfeits in the pharmaceutical supply chain and regulations mandating companies to deploy strategies such as serialisation and to have greater awareness, there is a need for innovative and effective solutions for product authentication, track and trace and supply chain integrity,” Selwyn Noronha, chief executive of ACG Capsules, said in a statement.

“We strongly believe that our association with Applied DNA is a step towards nipping the counterfeiting problem that is grappling the industry today. With the introduction of stricter regulatory norms and measures across the globe, the pressure lies increasingly in improving existing supply chain safeguards. This association will equip pharmaceutical companies with greater capabilities to thwart the threat of counterfeits by providing an amplified traceability solution across the supply chain.” 

APDN’s core technology is known as SigNature, which forms the basis of the firm’s security and authentication products, such as SigNatureT and fiberTyping, targeted towards textiles and apparel, BackTrac and DNAnet, for anti-theft and loss prevention, and digitalDNA, for track and trace. 

In the current deal with ACG, the SigNature technology will be used to embed a bespoke molecular tag into one or more capsule component materials. Each customer’s molecular tag can be formulated to specifically adhere to a wide variety of substrates and is optimised to allow for authentication at any point in the pharma supply chain. 

Commenting on the MoU, Dr James Hayward, president and chief executive of APDN said: “We are proud to announce the signing of the MoU and are excited by ACG’s development of on-dose authentication for hard-shell capsules powered by the company’s SigNature molecular tagging and authentication technologies. The ability to forensically test a capsule in the field and quickly prove its provenance is a powerful tool for all nodes of the pharmaceutical supply chain and will ensure a more secure and traceable global pharmaceutical supply chain.” 

APDN has had ambitions to secure the pharma supply chain for several years and has been making inroads into the industry. 

At the end of last year, it formed an alliance with excipient and coating specialist Colorcon for the commercialisation of DNA-based taggants. The deal will combine APDN’s molecular taggant and authentication markers with Colorcon’s portfolio of film coating systems, inks and colour dispersions for use in solid oral dosage forms.

The company is also awaiting an upcoming filing of a Drug Master File with the US Food and Drug Administration, which the company sales allow it to pursue revenue opportunities with pharmaceutical companies in a more vigorous manner as new drug applications will be able to refer to the DMF directly without additional study.