SBIR Phase II: Serialized Anti-Counterfeit Labeling Technology for Pharmaceutical and Biological Products

The broader impact of this Small Business Innovation Research (SBIR) Phase II project is on the mitigation of the worldwide counterfeit drug market which has a significant impact on public health, brand integrity, and revenue. Specifically, this project aims to develop a state of the art, counterfeit-proof, ID security technology that enables vaccine and biologic manufacturers to tag, track, and authenticate its products throughout the supply chain.

The technology involves a scalable manufacturing process that imprints a covert and highly encrypted pattern onto a label that may be placed on individual vaccine vials. The imprinted pattern produces an image that may only be read with a proprietary interrogation process. Additionally, each label incorporates a serialized code.

The focus of this serialization is to provide each dose, each vial, with its own unique signature or fingerprint. The serialization aspect of the labels is significant for vaccine/biologic manufacturers, as this enables traceability of dosage form throughout the supply chain, a mandate required by global regulatory agencies.

The proposed project aims to provide both the pharma industry and the global health community with tagging technology that ensures supply chain integrity for drug products throughout the world. Specifically, the focus of the Phase II effort is to: 1) demonstrate the scalable production of computationally designed tags, 2) integrate an automated tagging and reading process directly with a drug product manufacturing line, and 3) demonstrate the production and use of a handheld reader that enables authentication of product at any point in the supply chain.

An ID technology that differentiates authentic from counterfeit products is anticipated at the conclusion of the effort. The authentication process will reveal product composition, origin of manufacture, date of manufacture, expiration, and other pertinent information. The labels will withstand temperatures typically encountered during storage and will also incorporate various degrees of tamper evident and tamper proof characteristics.

This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.