Providing security solutions
for a complex, global supply chain

Pharmaceutical Supply Chain Security: Benefits of DNA Molecular Tags

  • DNA Molecular Tags cannot be copied

  • DNA Molecular Tags are inert, inactive and safe

  • Custom DNA Molecular tags are created for each product/company/geography

  • Highly resilient and compatible with virtually any material

  • Traceable at molecule levels (parts per billion/trillion in the tablet)

  • Can be incorporated in the pharmaceutical grade ink used on tablets

  • Can be put into the coating material that goes on the tablet

  • Can be added to any of the ingredients in the tablet

  • Can be added to the ink that imprints the barcode on the box or packaging

  • Can be put into the ink that prints the logo

  • Authenticated with field readers and in lab analysis

  • Forensically secure

  • Accepted by courts

  • Fits within FDA Guidance on the use of DNA in pharmaceuticals

How to Fully Secure the Pharmaceutical Supply Chain

Complex, Global Pharmaceutical Supply Chain

Manufacturing today is done on a highly complex, global and often fragmented scale. Possibility of disruption, obstacles and risks become higher given the number of touch points in a long and global chain. With the increase of product diversion, and counterfeiting, companies could be at significant risk if the supply chain is not fully secured.
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FDA Mandated Serialization (Track & Trace)

As part of the 2013 US Drug Quality and Security Act, and regulations in countries such as Japan, China, India, Turkey and others, pharmaceutical companies are already in the process of serializing their products through the supply chain. Much of the current strategy of serialization involves bar codes.
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Current Bar Codes Are NOT Fully Secure

2D bar codes are able to track and trace products throughout the supply chain. However, bar codes can be copied using any smartphone and a printer. Using technology available everywhere, bar codes can be easily copied onto a possibly dangerous package which may be inserted into a company’s supply chain.
 
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Innovative, Fully Secure Solution is Here

Using the breakthroughs in forensics, nanotechnology, chemistry, biology and biotechnology, Applied DNA Sciences has been able to commercialize a fully secure, end-to-end solution to fully secure the global pharmaceutical supply chain.
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Create DNA Molecular Tags Derived From Plants

Nature gives us the ultimate bar code that is unbreakable, cannot be copied and cannot be seen by the naked eye. Our DNA Molecular Tags are created in a laboratory in Stony Brook, NY and customized for each product (container, lot, batch, unit, dose, etc.). DNA Molecular Tags are the latest advances in fully securing patient safety, ensuring compliance and reducing risk for pharmaceutical companies.
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DNA Molecular Tags Applied to Tablets Via Ink

Through our partners, DNA Molecular Tags have been applied to pharmaceutical-grade, edible ink that would be utilized for printing on pharmaceutical capsules or tablets. Applied in parts per billion or in some cases, parts per trillion as the overall component in the tablet or capsule, DNA Molecular Tags are safe and t within the FDA guidance on the use of DNA as a pharmaceutical chemical identier (PCID) in solid oral dosage forms (SODF).

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DNA Molecular Tags Applied to Pharmaceutical Packaging

Utilizing ink as a carrier, DNA Molecular Tags can be applied to the packaging of any pharmaceutical product, fully securing the package. Bar code labels can be printed with the DNA Molecular Tag, enabling complete track and trace.
 
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Test Packaging and Tablets/Capsules Before Shipping

Each time a package of tablets or capsules leaves the manufacturing site, Applied DNA Sciences technology offers an opportunity to test for the presence of the DNA Molecular Tag on product and/or packaging.
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Shipped to Distributors Globally

Pharmaceutical products often touch a dozen or more ports or points around the world before reaching your local pharmacy.
 
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Tested in Warehouse

Upon landing in any warehouse, the pharmaceutical package or tablet/capsule can be tested using Applied DNA Sciences’ authentication devices to verify that the product that left manufacturing is the product that reached the warehouse, ensuring a fully secure distribution chain.
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Spot Tested in Pharmacy

When getting ready to dispense the pharmaceutical tablet/capsule to a patient, a pharmacist can determine authenticity, either through the package or the tablet/capsule. The presence of a proper DNA Molecular Tag offers the patient reassurance that dispensed medicine is real.
 
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Forensic Testing in Laboratory (If Required)

At our state-of-the-art Forensics Laboratory in Stony Brook, NY, Applied DNA Sciences performs a thorough examination and analysis of the pharmaceutical packaging or tablet/capsule to provide companies with a full detailed report of findings and a Confidential Forensics Report that is admissible in a court of law.
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Reduce Risk, Improve Safety and Ensure Compliance

Pharmaceutical companies can be more confident that serialization is fully secure and uncopyable, reducing risk, ensuring compliance with FDA requirements, promoting safety and TRUST for patients.

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Patients Feel Safe & Confident in Brand

Doctors and patients can feel secure and safe in their medicine because of clarity, transparency and now full security of the global supply chain.

Contact us for more information

Bob Miglani
Chief of Business Development
bob.miglani@adnas.com