Rapid authentication of pharmaceuticals via DNA tagging and field detection

PLoS One. 2019 Jun 13;14(6):e0218314. doi: 10.1371/journal.pone.0218314. eCollection 2019.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • DNA / chemistry*
  • Humans
  • Pharmaceutical Preparations / analysis*
  • Polymerase Chain Reaction / methods

Substances

  • Pharmaceutical Preparations
  • DNA

Grants and funding

This study was funded by Applied DNA Sciences, Inc.; a publicly traded company (NASDAQ: APDN) http://adnas.com/. Authors are employed by Applied DNA Sciences, Inc., which provided support in the form of salaries for all authors and decision to publish the results but did not have any additional role in the study design, data collection and analysis or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.