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.
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.
About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable
supply chain security, anti-counterfeiting and anti-theft
technology, product genotyping and pre-clinical nucleic acid-based
therapeutic drug candidates.
Applied DNA makes life real and safe by providing innovative,
molecular-based technology solutions and services that can help
protect products, brands, entire supply chains, and intellectual
property of companies, governments and consumers from theft,
counterfeiting, fraud and diversion.
Visit adnas.com for more information. Follow us on Twitter and
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Common stock listed on NASDAQ under the symbol APDN, and
warrants are listed under the symbol APDNW.
Forward-Looking Statements
The statements made by Applied DNA in this press release may be
“forward-looking” in nature within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements describe Applied DNA’s future plans, projections,
strategies and expectations, and are based on assumptions and
involve a number of risks and uncertainties, many of which are
beyond the control of Applied DNA. Actual results could differ
materially from those projected due to its ability to continue as a
going concern, its history of net losses, limited financial
resources, limited market acceptance, uncertainties relating to its
ability to maintain its NASDAQ listing in light of delisting
notices received and its recent hearing, and various other factors
detailed from time to time in Applied DNA’s SEC reports and
filings, including our Annual Report on Form 10-K filed on December
18, 2018, as amended, our subsequent quarterly reports on Form 10-Q
filed on February 7, 2019, May 9, 2019 and August 13, 2019, and
other reports we file with the SEC, which are available at
www.sec.gov. Applied DNA undertakes no obligation to update
publicly any forward-looking statements to reflect new information,
events or circumstances after the date hereof or to reflect the
occurrence of unanticipated events, unless otherwise required by
law.
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Investor contact: Sanjay M. Hurry, LHA Investor Relations,
212-838-3777, shurry@lhai.com Program contact: Judy Murrah,
CIO, 631-240-8819, judy.murrah@adnas.com web: www.adnas.com
twitter: @APDN
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