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Molecular Tagging of Pharmaceutical Excipients Utilizing Applied DNA’s

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RodeKroet   Friday, 10/04/19 05:17:29 AM
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Molecular Tagging of Pharmaceutical Excipients Utilizing Applied DNA’s Technology Published in Peer-Reviewed Journal
International Journal of Pharmaceutics publication evaluates a proprietary method to tag pharmaceutical excipients. Study conducted at King’s College London with Collaborators from Dubai Police and Applied DNA concludes the proprietary method of DNA tagging excipients can mitigate the risks of counterfeit drugs.
STONY BROOK, N.Y., October 4, 2019 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA”), a leader in large-scale PCR-based DNA manufacturing, announced today that a scientific paper entitled, ‘Anti-counterfeiting DNA molecular tagging of pharmaceutical excipients: An evaluation of lactose containing tablets’, has been published in the International Journal of Pharmaceutics, detailing a novel Physical-Chemical Identifier (PCID) to authenticate and track legitimate pharmaceutical products through the pharmaceutical supply chain.

The study carried out by a team led by Dr. Royall at the Institute of Pharmaceutical Science, King’s College London and Dr. Altamimi from the Department of Forensic Evidence & Criminology, Dubai Police HQ, UAE, evaluated the use of DNA molecular tags as a potential anti-counterfeiting technology in tablets. Lactose tablets were used as a model of a solid dosage form. Analysis for in-field DNA authentication was carried out using a portable Applied DNA SigNify® qPCR instrument. Tablet batches were subjected to accelerated stability conditions for 6 months with the DNA tag clearly detected in all tablets after the storage period. All tablet batches passed the monograph specifications of the British Pharmacopoeia throughout the storage period. The study concluded that DNA molecular tags could feasibly be applied within the pharmaceutical development cycle when a new solid dosage form is brought to the market so as to mitigate the risk and dangers of counterfeiting.

“We believe DNA tagging of inks, coatings, and other ingredients are candidates for use in the pharmaceutical supply chain, securing authenticity of an individual tablet or capsule from the manufacturer, to the distributor, and finally the pharmacy. We believe authentication is possible, even when the product is separated from packaging, making it a complement to serialization and a platform to be considered as a weapon against today’s most difficult and global challenges, such as the opioid crisis,” said Dr. James Hayward, president and CEO, Applied DNA.

The licensed pharmaceutical industry and regulators use many approaches to control counterfeiting, but it remains a very difficult task to differentiate between counterfeit and real products. Moreover, there is a lack of techniques available for providing a batch-specific molecular bar code for tablets and other solid oral dosage forms that require traceability, specificity and sensitivity to be fit for purpose.

“Counterfeit drugs represent a large and growing problem for the global pharmaceutical industry and can lead to serious illness or death. Publication of our methods and systems for molecular tagging of pharmaceuticals is a seminal development in our industrial deployment, and acceptance of our methods by scientific peers is a welcome endorsement,” said Dr. Michael Hogan, vice president, Life Sciences, Applied DNA.

“Many tablets contain lactose; thus, it was sensible to use this popular excipient in our proof of concept study. Lactose presented a good challenge to Applied DNA’s technology as it is a reducing sugar and in combination with the high temperature and high humidity storage conditions, it formed a harsh environment to test the stability of the molecular tags. The DNA tags performed exceptionally well, and were able to be easily detected after six months of storage. We believe this study shows the potential of the technology to provide traceability beginning with the powdered ingredients right through to the fully formed medicine,” said Dr. Paul Royall, Senior Lecturer in Pharmaceutics, King’s College London.

About the Institute of Pharmaceutical Science, King’s College London
The Institute of Pharmaceutical Science at King’s College London is part of the Faculty of Life Sciences & Medicine. The Institute has a flourishing research effort in the fields of drug discovery, medicines development and medicines use, and has approximately 100 registered postgraduate research students. Through the Department of Pharmacy, the Institute provides initial education and training for pharmacists through the MPharm program and provides a range of specialist postgraduate taught courses in Pharmaceutical Science, Pharmaceutical Medicine and Clinical Pharmacy.

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