WuXi PharmaTech, an open-access R&D capability and technology platform company, and TruTag Technologies, a developer of an edible security platform for pharmaceuticals, have successfully completed joint testing of TruTag’s on-dose authentication solution.
TruTags’ solution allows a digital scan of a drug to confirm its authenticity and reveal provenance information such as manufacturing location, dosage, images of packaging, expiration date, supply chain data and lot or batch number. WuXi and TruTag Technologies first announced their alliance in 2014, including an investment by the WuXi Venture Fund in TruTag.
TruTags can be applied to qualifying solid oral dosage form (SODF) products using a consistent, repeatable process. No new manufacturing equipment and changes in manufacturing processes are needed. After application on manufactured tablets, TruTags are successfully detected using TruTag’s proprietary optical detection device. Apart from this detection process, TruTags are covert and not visually identifiable and remain with the tablet for its entire life. Once applied, the TruTag solution did not affect the stability or dissolution properties of API drugs in completed accelerated open and closed bottle testing. Implementing the TruTag solution on existing drugs requires minimal regulatory reporting changes for drug manufacturers and complies with the physical-chemical identifier (PCID) guidance issued by the FDA in 2011.
WuXi and TruTag now will begin further testing of TruTags on additional API products. They also will produce a technical white paper for the industry detailing the results of the application method and practice, the detection process and data collection, and outcomes of dissolution and stability testing. TruTag already is working with several multinational pharmaceutical companies in pilot testing for broad deployment of this technology in marketed SODF drugs and product candidates.
“One can think of TruTags as a form of edible PIATS, or Product Identification Authentication Tracking System, which can be embedded into a product like unique fingerprints,” said Hank Wuh, M.D., MPH, TruTag Technologies’ founder and chairman. “With our ability to securely identify individual goods without labels or packaging, we aim to dramatically improve the safety and traceability of critical products such as food and medicine and, in the process, to have a fundamental impact on big data.”