DNA-Based Chemical Unclonable Functions for Cryptographic Anticounterfeit Tagging of Pharmaceuticals.

Abstract

Counterfeit products are a problem known across many industries. Chemical products such as pharmaceuticals belong to the most targeted markets, with harmful consequences for consumer health and safety. However, many of the currently used anticounterfeit measures are associated with the packaging, with the readout method and level of security varying between different solutions. Identifiers that can be directly and safely mixed into the product to securely authenticate a batch would be desirable. For this purpose, we propose the use of chemical unclonable functions based on pools of short random DNA oligos, which allow the integration of a cryptographic authentication system into chemical products. We demonstrate and characterize a simplified workflow for readout, showing that results are robust and clearly differentiate between the correct tag and a counterfeit. As a proof of concept, we demonstrate the labeling of an acetaminophen formulation with a chemical unclonable function. The acetaminophen was successfully authenticated from a subsample of the product at a DNA admixing concentration of below 50 ng/g. Stability tests revealed that the readout is stable at room temperature for several years, exceeding the shelf life of most drug products. Our work thus shows that chemical unclonable functions are a valid alternative to state-of-the-art anticounterfeit methods, enabling a secure authentication scheme that is physically linked to the product and safe for consumption. The method is widely applicable beyond pharmaceuticals, allowing for more secure product tracing across industries.