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Emerging anticounterfeiting technologies offer pharmaceutical manufacturers more options for supply chain security.
A wide variety of anticounterfeiting measures are available to pharmaceutical manufacturers today. Taggants, whether added directly to the drug or to packaging, are attracting interest. TruTag Technologies offers its taggants for use in on-dose production, not only for commercial products but for medications in development. “This approach allows customers to hit the ground running upon approval of the drug, with a known cost, standard operating procedures, and logistics plan,” says TruTag President, Kent Mansfield. He notes that taggants will be used in products that are expected to be commercialized in the United States, Europe, and Asia next year. The company’s facility received cGMP qualification in 2016, and TruTag has been working with partners, Colorcon and WuXi PharmTech, to test its technology in new products.
Applied DNA is working with two companies to determine the feasibility of embedding its taggant technology onto tablets and capsules, says Robert Miglani, chief of business development. The company is also developing plans to offer outsourced forensic testing services, he says.
In addition, authentication capabilities are becoming more important, both in regions where serialization mandates do not yet exist, and as manufacturers focus on preventing diversion of crucial therapies such as injectable cancer drugs, says Systech’s Jim Sinisgalli, director of brand protection solutions. Early authentication technology offered a “yes or no” answer to whether product was real or not. Today, technology can handle many use cases, including counterfeiting and diversion. “Once you can prove uniqueness, you can also provide important metadata with each item, such as where the item has been, where it is supposed to go, lot number, expiration date, active ingredient, source and manufacturing plant, as well as enabling authentication data from the field, which can be accessed via a smart phone application,” he says. The company is evaluating Internet of Things (IoT) approaches, and starting to look at the possibilities of blockchain, or advanced digital ledger technology, which could play an important role in helping to secure the pharma supply chain in the future.
Vol. 41, No. 9
When referring to this article, please cite it as A. Shanley, “A Growing Number of Options,” Pharmaceutical Technology 41 (9) 2017.C