Rapid authentication of pharmaceuticals via DNA tagging and field detection.

A small PCR-generated DNA fragment was introduced into a pharmaceutical grade ink as a molecular taggant, and the DNA tagged ink was delivered onto the surface of capsules by standard high-speed offset printing. The amount of DNA in the ink on each capsule is roughly 10-12 fold lower than that allow...

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Main Authors: Lawrence Jung, Michael E Hogan, Yuhua Sun, Benjamin Minghwa Liang, James A Hayward
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2019-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0218314
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author Lawrence Jung
Michael E Hogan
Yuhua Sun
Benjamin Minghwa Liang
James A Hayward
author_facet Lawrence Jung
Michael E Hogan
Yuhua Sun
Benjamin Minghwa Liang
James A Hayward
author_sort Lawrence Jung
collection DOAJ
description A small PCR-generated DNA fragment was introduced into a pharmaceutical grade ink as a molecular taggant, and the DNA tagged ink was delivered onto the surface of capsules by standard high-speed offset printing. The amount of DNA in the ink on each capsule is roughly 10-12 fold lower than that allowed as safe by the United States Food and Drug Administration (FDA) and the WHO with regards to acceptable limits of residual DNA. The printed ink on the capsule surface was sampled by swabbing, followed by direct analysis of the DNA-swab complex, without subsequent DNA purification. It was shown that DNA recovered from the ink by swabbing was suitable for PCR-CE analysis-a widely used method in forensic science and was also suitable for qPCR and isothermal DNA amplification, when coupled with portable devices similar to those used for environmental sampling and food safety testing. The data set a precedent: A small DNA fragment could be introduced as an excipient into a pharmaceutical application, and thereafter tracked through the pharmaceutical supply chain via forensic DNA authentication.
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spelling doaj.art-029621d31bd648a6bb04c11607d983852022-12-21T18:38:22ZengPublic Library of Science (PLoS)PLoS ONE1932-62032019-01-01146e021831410.1371/journal.pone.0218314Rapid authentication of pharmaceuticals via DNA tagging and field detection.Lawrence JungMichael E HoganYuhua SunBenjamin Minghwa LiangJames A HaywardA small PCR-generated DNA fragment was introduced into a pharmaceutical grade ink as a molecular taggant, and the DNA tagged ink was delivered onto the surface of capsules by standard high-speed offset printing. The amount of DNA in the ink on each capsule is roughly 10-12 fold lower than that allowed as safe by the United States Food and Drug Administration (FDA) and the WHO with regards to acceptable limits of residual DNA. The printed ink on the capsule surface was sampled by swabbing, followed by direct analysis of the DNA-swab complex, without subsequent DNA purification. It was shown that DNA recovered from the ink by swabbing was suitable for PCR-CE analysis-a widely used method in forensic science and was also suitable for qPCR and isothermal DNA amplification, when coupled with portable devices similar to those used for environmental sampling and food safety testing. The data set a precedent: A small DNA fragment could be introduced as an excipient into a pharmaceutical application, and thereafter tracked through the pharmaceutical supply chain via forensic DNA authentication.https://doi.org/10.1371/journal.pone.0218314
spellingShingle Lawrence Jung
Michael E Hogan
Yuhua Sun
Benjamin Minghwa Liang
James A Hayward
Rapid authentication of pharmaceuticals via DNA tagging and field detection.
PLoS ONE
title Rapid authentication of pharmaceuticals via DNA tagging and field detection.
title_full Rapid authentication of pharmaceuticals via DNA tagging and field detection.
title_fullStr Rapid authentication of pharmaceuticals via DNA tagging and field detection.
title_full_unstemmed Rapid authentication of pharmaceuticals via DNA tagging and field detection.
title_short Rapid authentication of pharmaceuticals via DNA tagging and field detection.
title_sort rapid authentication of pharmaceuticals via dna tagging and field detection
url https://doi.org/10.1371/journal.pone.0218314
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