On-dose authentication technology is piloted in an international test

Using taggants to prove the authenticity of pharma products has been long-sought goal of a variety of technology developers; now, a new collaboration among three firms might gain traction. The effort, however, is the latest in many similar projects in recent years that the pharma industry has shown little enthusiasm for.

The new collaboration is among TruTag, developer of a silica-based taggant that can be coded with product information; Colorcon, a leading supplier of coatings and excipients for solid-dose pharmaceuticals; and PwC Australia, which has developed a blockchain-based networking technology. The three companies conducted a simulation over the past year in which placebo pills, coated by Colorcon with the TruTag taggant, were shipped internationally, then authenticated by linking on-the-spot analysis with the PwC network.

TruTag has been marketing its taggant since 2010; along the way, it developed a smartphone/camera app to verify the taggant ID (a proprietary TruTag device can also be used). The silica substrate for the identification meets Generally Recognized as Safe (GRAS) standards; it also fits with the “physical-chemical identifiers” designation that FDA defined in 2011. However, at least according to TruTag’s public statements, its only commercialization was announced in 2017 with a nutritional supplements manufacturer. Earlier this year, it announced partnerships with Colorcon and with PwC; the latter organization is developing a blockchain-based network for characterizing food supply chains.

On-dose tagging, as promoted by TruTag, is one approach to authentication. In recent years, a variety of other on-dose techniques have been used, ranging from laser writing to DNA-based materials. Alternatively, several companies offer methods to authenticate the label on the product package, including Covectra and Systech International. TruTag is eager to point out that the Drug Supply Chain and Security Act (DSCSA), the 10-year, multibillion-dollar program that the US industry is engaged in, will not provide certain authentication of products (a point that most DSCSA experts agree with), but the question remains whether pharma companies are sufficiently concerned about counterfeiting to add authentication to their DSCSA compliance duties.

12/24 UPDATE: according to a 12/23 news release from Applied DNA Sciences--the company with DNA-based taggants--Colorcon and Applied DNA are collaborating on an "On-Dose Authentication" service. The news release quotes Kelly Boyer, GM, Film Coatings at Colorcon, stating that “On-dose authentication technology represents the next generation in pharmaceutical supply-chain security by providing a powerful tool for tracking product from plant to patient." A white paper on the topic is available in Colorcon's latest enewsletter.