WuXi PharmaTech (Cayman) Inc. and TruTag Technologies, Inc. have announced the successful completion of joint testing of TruTag's on-dose authentication solution.
TruTags offer a unique solution for drug manufacturers, allowing 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 announced their alliance in 2014, including an investment by the WuXi Venture Fund in TruTag.
TruTags have a number of benefits for pharmaceutical manufacturers that were confirmed in this joint testing:
• 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 U.S. Food and Drug Administration in 2011.
WuXi and TruTag will now begin further testing of TruTags on additional API products. They will also 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 is already working with several multinational pharmaceutical companies in pilot testing for broad deployment of this technology in marketed SODF drugs and product candidates.
"We are very excited about these results," said Dr. Ge Li, Chairman and CEO of WuXi PharmaTech. "At WuXi, we are always seeking cutting-edge solutions like TruTags to help support the development and protection of our customers' innovative products."
President of TruTag Technologies, commented, "We are excited to confirm these results in testing conducted with our partner WuXi PharmaTech, an innovative company that values its customers' IP and patients' safety. We have demonstrated the ability of our technology to integrate an edible and safe identification code directly into an oral solid drug, thereby indelibly marking the product with an internal code for its lifetime. In the near term, this will allow drug manufacturers and distributors to have the ultimate audit of a drug's provenance and origin without reliance on packaging or laboratory chemical analysis."
"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, MD, 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."