Medical Device Link.

TRACK AND TRACE

NanoInk Inc. (Skokie, IL) is used to working outside the public eye. The company specializes in nanometer-scale manufacturing for the life science and semiconductor industries. For pharmaceutical firms looking to add security features to their products, it offers its nanoencryption technology, a layered process based on proprietary nanolithographic encryption.

Cédric Loiret-Bernal, MD, CEO of NanoInk, says that nanoencryption involves encrypting each batch of product with three levels of security features: semicovert, covert, and forensic. (NanoInk is working on second-generation technology that will have up to five levels.) But Loiret-Bernal won’t say what any of those features are or how they are created or deposited. He does say that reverse engineering is difficult and costly.

“Many of the other security technologies in the market are already known by several parties,” says Loiret-Bernal. “The value of our technology is that it is not known by anyone unless they are under confidentiality agreement.”

Even then, the nanoscale features are “optimized to a particular product or company,” Loiret-Bernal says.

NanoInk’s current approach involves placing nanoscale security features on individual tablets. Invisible to the naked eye, these encrypted features can link product to package for a multiple-level solution. “An authentic package does not certify authentic content,” claims NanoInk in a company brochure. “Technologies like RFID, color-shifting dyes, and marking schemes work overtly or at the package level.” But “covert batch traceability at the unit level” is needed.

According to NanoInk, each nanoencrypted tablet “is directly linked to granular batch-specific data, including serial number, manufacture date, manufacture location, and supply-chain ship-to locations.” Pharmaceutical firms determine which encryptions are used on each tablet and whether to change them from batch to batch.

The technology offers many variables, and it has a lot of flexibility, he reports. It was designed to be easily incorporated into existing manufacturing processes, and it is neutral to any packaging solutions. It does not change the product formulation, claims Loiret-Bernal.

Nanoscale cryptography can only be detected with highly specialized authentication tools located at centralized NanoInk centers. Counterfeit drugs can be identified by the absence of nanoencryption, and these suspect products are flagged as mismatches during the authentication process. “This stringent, molecular-scale lock-and-key model ensures complete brand security through all points in the supply chain,” says Loiret-Bernal. Non-destructive authentication is performed within 24 to 48 hours, providing forensic evidence.

Six authentication centers are targeted to provide global authentication: two in the United States, two in Europe, and two in Asia. Some are NanoInk facilities; others are operated in conjunction with regulatory agencies. “FDA has looked at our approach,” he says. “We aim for jointly operated facilities with FDA support by government funds.”

Loiret-Bernal says that pharmaceutical companies must protect their brand integrity while continuing to run efficient and cost-effective production processes. “Business is good for the bad guys right now. Ten percent of drugs worldwide are counterfeit,” he reports. Unfortunately, “the supply chain is more part of the problem than part of the solution. Full manufacturing traceability for each tablet, for instance, would go a long way.”