36 October 2018 Tablets & Capsules
ing, chain-of-custody management, and other measures
for storing and transporting both the taggant and the
resulting product.
Drug product authenticity and traceability are critical
for patient safety. The pharmaceutical industry has
already begun using DNA molecular tagging in film coat-
ings and capsule shells and is exploring DNA molecular
tagging as one of many solutions to help fight drug coun-
terfeiting—both inside and outside the box. T&C
References
1. Peter Behner, Marie-Lyn Hecht, and Fabian Wahl,
"Fighting counterfeit pharmaceuticals: New defenses for
an underestimated—and growing—menace," June 29,
2017, https://www.strategyand.pwc.com/reports/counter
feit-pharmaceuticals.
2. US FDA Center for Drug Evaluation and Research
(CDER), "Guidance for Industry: Incorporation of
Physical Chemical Identifiers into Solid Oral Dosage
Form Drug Products for Anticounterfeiting," October
2011, https://www.fda.gov/downloads/drugs/guidances/
ucm171575.pdf.
3. Mike DeHaan, "Comparing the Genetic Code of
DNA to Binary Code," August 25, 2015, https://www.
decodedscience.org/comparing-genetic-code-dna-bina
ry-code/55476.
4. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfCFR/CFRSearch.cfm?fr=170.30.
5. https://www.fda.gov/Food/GuidanceRegulation/
G u i d a n c e D o c u m e n t s R e g u l a t o r y I n f o r m a t i o n /
Biotechnology/ucm096095.htm.
6. US FDA, "Guidance for Industry: Characterization
and Qualification of Cell Substrates and Other Biological
Materials used in the Production of Viral Vaccines for
Infectious Disease Indications," February 2010, http://
www.fda.gov/downloads/biologicsbloodvaccines/
guidancecomplianceregulatoryinformation/guidances/
vaccines/ucm202439.pdf.
Judy Murrah is chief information officer at Applied DNA
Sciences (631 240 8800, www.adnas.com).
lar taggant would arrive at the company's manufacturing
facility in small vials in liquid or powder form. Following
the manufacturer's instructions, the company would add
the taggant during its standard production process, by
mixing it into the tablet coating powder, capsule shell
shellac, SODF ink, or packaging ink or varnish.
Companies can now buy standard industry inkjet
equipment for printing variable date/lot code serialization
information with secure ink pre-tagged with their specific
DNA molecular taggant identifier. Pre-tagged ink is
available in black or clear, allowing for covert serializa-
tion that can be illuminated with UV light. No produc-
tion process changes are required. To use the taggant in
varnish or flexographic ink on the package, the company
would mix the taggant into the carrier prior to printing.
Upon completing a batch, the company tests the
product using a portable DNA authentication device as
part of standard QC protocols to verify that the right
taggant has been applied at the right concentration to
ensure subsequent supply-chain authentications. The
authentication process requires only a trace of product
and provides results in less than an hour.
For future authentications in the supply chain, the tag-
gant is extracted using either a water swab of the surface
or by completely dissolving the coating or entire SODF
in water and running the material on the authentication
device. Proactive supply chain testing can detect and
deter adulteration, diversion, or other risks immediately.
Reactive testing involves investigating a problem after it
occurs and the damage has already been done.
As with any product, companies must observe strict
security protocols to further deter nefarious actions.
These should include the use of tamper-evident packag-
Photo 2: Pre-tagged ink is available in black or clear, for covert
serialization that can be illuminated with UV light.
