Providing authenticity and traceability solutions for pharmaceuticals and dietary supplements
Pharmaceutical and Dietary Supplement Supply Chain Security
Benefits of SigNature molecular tags
- Protect against IP adulteration, counterfeiting or diversion
- Not practical to copy
- Inert, inactive and traceable at parts per billion in the solid oral dosage form (SODF)
- Custom tags can be created for each product/company/geography
- Highly resilient and compatible with virtually any material
- Can be incorporated in the ink or coating material used on tablets
- Can be added to pharmaceutical ingredients, excipients, coatings, colorants and inks for bulk product or solid oral dosage forms
- Can be added to the packaging
- Authenticate with field readers and in lab analysis
- Forensically secure
- Accepted by courts
- Designed to follow FDA Guidance on Physical-Chemical Identifiers
Applied DNA Sciences is a participant in the FDA’s Emerging Technology Program.
Together we offer proactive regulatory support throughout your SigNature molecular tag implementation.
Colorcon On-Dose Authentication Platform
Colorcon launched the On-Dose Authentication platform to provide track and trace functionality for supply chain security. The seamless integration of SigNature molecular tags into an Opadry® fully formulated film coating system significantly reduces the risks associated with counterfeit and falsified medications entering the supply chain.
Kelly Boyer, General Manager, Film Coatings at Colorcon Inc. explains “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. By seamlessly enabling authentication, these digitized coatings confirm the quality and origin of medicines thereby safeguarding both patients and brands.”
Daniel To presented ‘Novel Authentication Technology Using Molecular Tags as a PCID in Solid Oral Dosage Forms’, a collaboration with Applied DNA Sciences, at AAPS 2019. See the poster here.
Molecular tagging and authentication of capsule shell ink utilizing Applied DNA’s technology published in peer-reviewed journals
Rapid authentication of pharmaceuticals
via DNA tagging and field detection
Read article at PLOS ONE
PLOS ONE publication details proof-of-concept methods to authenticate legitimate pharmaceutical drugs
Read article at The International Journal of Pharmaceutics
Research study simulates the use of SigNature molecular tags to mitigate the risk and dangers of counterfeiting
Problem Statement
COMPLEX, GLOBAL 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.
FDA MANDATED SERIALIZATION
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 on packaging.
CURRENT BARCODES ARE NOT SECURE
Two-dimensional bar codes are able to track and trace products throughout the supply chain. However, bar codes can be copied using ubiquitous items such as smartphones and printers. These fake bar codes can find their way to a possibly dangerous package, and in turn, a company’s supply chain. The tablets or capsules or dietary ingredients can also become separated from their packaging, causing them to lose their identity and traceability.
An Innovative, Fully Secure Solution is Here
Using the breakthroughs in forensics, nanotechnology, chemistry, biology and biotechnology, Applied DNA has commercialized a fully secure end-to-end authenticity and traceability security solution
SigNature Molecular tags can be customized for each product.
Molecular tagging supports patient safety and evidence of IP and manufacturing compliance to reduce risk for pharmaceutical and dietary supplement companies.
Tag Pharmaceutical Tablets with Molecular Ink
Molecular tags may be added to pharmaceutical grade inks used for printing on capsules or tablets. Applied in parts per billion or trillion as the overall component in a dose, molecular tags are designed to be aligned to the FDA Guidance on the use of DNA in pharmaceuticals as a physical-chemical identifier (PCID) in solid oral dosage forms (SODF).
Secure, Traceable Packaging
Molecular tags can be applied to the packaging of any pharmaceutical or dietary supplement product, fully securing the package. Bar code labels can be printed with SigNature molecular ink, enhancing complete track and trace.
Test at Warehouse
Upon arriving in any warehouse, the pharmaceutical / dietary supplement package or tablet/capsule could be tested using Applied DNA’s authentication devices to verify that the product that left manufacturing is the product that reached the warehouse, ensuring a fully secure distribution chain.
Test at Pharmacy
Prior to dispensing to a patient, a pharmacist could determine authenticity through the package or the tablet/capsule. The presence of the assigned SigNature molecular tag offers the patient reassurance that their medicine is real and safe.
Test In Forensic Lab
If required, Applied DNA will perform a thorough examination and analysis of the sample to provide clients with a full detailed report of findings, as well as an authentication report that is admissible in a court of law.
Companies reduce risk, improve safety and ensure compliance
Pharmaceutical companies can be more confident that serialization is fully secure and able to be differentiated from photocopied graphics and bar codes, reducing risk, supporting compliance with FDA requirements, and promoting safety and TRUST for patients.
Patients feel safe and confident in brand
Healthcare professionals and patients should feel secure with their medicine because of clarity, transparency and now full security of the global supply chain.
