On-dose product authentication will get a commercial tryout

It’s taken years, but NanoGuardian (Skokie, IL) has its first commercial contract to deploy its optical security technology on a commercial pharma product. The technique, NanoEncryption, is able to emboss a number, symbol or code on the surface of pharmaceutical pills—without using any additive or taggant that requires FDA review, according to the company. The code can be viewed with a high-power loupe, but there are also ways to incorporate covert codes into the viewable one. NanoGuardian, which has been marketing the technology for several years, has always been coy about how NanoEncryption works, but the company’s parent, NanoInk, Inc. has developed nanolithography for use in materials and biological research. NanoEncryption can be deployed on a vial cap or a single-use syringe as well as on-dose.

The client is only identified as a “Top 10 global pharma manufacturer,” and NanoGuardian would not confirm whether this client was the same one (also unnamed) who had submitted a proposal to test the technology to FDA several years ago. “The pharmaceutical company has decided it best to remain unnamed at the moment and thereby keep the use of the robust NanoEncryption technology confidential to maximize the chance of catching downstream supply chain members who are dispensing counterfeit and illegally diverted versions of its products,” according to a statement by Dean Hart, chief commercial officer at NanoGuardian.

Included in the agreement is NanoGuardian’s Closed-Loop Protection System, its method of field-verifying product authenticity. Sample product is gathered at retail or other outlets, then sent to a product integrity center in Skokie where it can be examined. NanoGuardian has agreements with SDI (now part of IMS Health) and Altegrity International to assist in the service.