**Ahura Scientific TruScan™ Handheld Raman Spectrometer**

FDA Docket. FDA-2008-N-0121

*Technologies for Prescription Drug Identification, Validation, Track
and Trace, or Authentication; Request for Information*

Ahura Scientific, Inc., would like to provide information about our
TruScan Raman spectrometer in response to FDA's request for information
published in the Federal Register on March 20, 2008 (Docket No.
FDA-2008-N-0121).

The TruScan is a fully functional, self-contained unit including a Raman
spectrometer as well as an on-board computer and chemometric software.
It was introduced in early 2007 as a tool for pharmaceutical companies
to authenticate incoming raw materials, but it quickly gained attention
for its ability to differentiate between authentic and counterfeit
pharmaceuticals and is currently used by many of the world's leading
pharmaceutical companies for anti-counterfeiting investigations and
interdiction.

The TruScan addresses the authentication and validation aspects
referenced in FDAAA (Public Law 3580), Section 913 but does not in its
current form offer track and trace capabilities.

**Background**

Raman spectroscopy uses a beam of focused light (a 785 nm laser) to
excite a sample (such as a tablet, powder, or liquid) and then collects
the scattered light to create a spectrum unique to the sample
interrogated. The spectrum is characteristic of the molecular bonds in
the sample and as such every pharmaceutical has a unique, distinct
spectrum that serves as a discrete "fingerprint". The spectrum generated
by a sample reflects all the molecules in the sample. In the case of a
pharmaceutical dosage form, this may include the APIs, excipients, dyes,
coatings, and any other ingredients in the formulation.

The major advantage of the TruScan (and Raman spectroscopy in general)
is that, in contrast to other anti-counterfeiting solutions proposed, it
requires no expensive manufacturing changes and can be deployed
immediately for field inspection of pharmaceuticals.

**Strengths for Identifcation & Authentication**

The TruScan is designed to provide field personnel without analytical
chemistry experience with a handheld tool that provides similar
analytical capability to what is generally provided in forensic labs.

To begin, a single authentic reference sample generally suffices to
create a reference spectrum or signature of a particular drug's dosage
form. This signature can then be exported to any number of field units
via the internet or a physical Compact Flash (CF) card. When field users
want to test a sample, they simply select the name of the authentic drug
the sample purports to be, scan it, and get a pass/fail reading from the
TruScan in minutes or less. The TruScan effectively compares the
spectrum of the sample with that of the authentic reference and uses
proprietary statistical algorithms to determine whether the two spectra
are statistically similar enough to substantiate a "pass".

All data collected during sample scanning are saved on the unit and can
be downloaded securely at a later time in a number of file formats to a
central server.

The TruScan is a product derived from an earlier handheld Raman
spectrometer called the First Defender™ which Ahura Scientific has been
selling for several years in significant numbers to the US and foreign
military forces. As such, the unit is based on a design that passes the
military specification for field ruggedness, allowing it to withstand
shock, vibration, water, and temperature extremes. These features make
it readily used in field operations for identifying counterfeit drugs,
obviating the need for samples to be sent to a central forensic
laboratory staffed by chemists. This allows vastly increased throughput
of tested samples by inspectors with very minimal training.

**Limitations for Identification & Authentication**

No single analytical tool can be used to assess every single sample. In
our experience, working with a number of the world's largest
pharmaceutical companies and FDA's forensic laboratories themselves, we
estimate that the TruScan is able to provide pass/fail measurements on
roughly 80% of NDCs.

The main limitation is that some samples may have too much fluorescence
(or background noise) to acquire a reasonable reference spectrum.
Another limitation is opaque capsules through which the laser cannot
penetrate. Finally, there are certain drugs (such as acetaminophen) that
have such a strong Raman signal that the TruScan is not able to
differentiate between different concentrations of the active ingredient.

**Costs of Implementation and Use**

The base price for a TruScan is \$42,000. For an additional cost,
accessories such as a tablet holder, vial holder, and flexible probe as
well as a library of spectra can also be purchased. Extended warranties
of up to five years are also available.

There is no cost for consumables and the costs for maintaining a fleet
of TruScans is very minimal. There is no ongoing need for calibration,
so no dedicated personnel are required. 27/7/365 technical support is
available for TruScan users.

Implementation is extremely simple. Training to use the TruScan can be
completed in just an hour or two for field users and a few hours more
for personnel who will add reference signatures to the library. Once
reference signatures have been created, they can be instantly uploaded
to all fleet units via the internet and sampling can begin.

**Benefits to Public Health**

The TruScan enables regulatory agencies and law enforcement to identify,
seize, and destroy potentially dangerous counterfeit drugs. While
counterfeiters are constantly improving the appearance of their
counterfeits (both the dosage forms and the packaging), replicating the
exact chemical composition of authentic formulations of pharmaceuticals
is nearly impossible. TruScan is able to detect even very small
variations in formulations, facilitating easy detection of counterfeits.

While currently FDA and other regulatory or enforcement bodies are
limited in their ability to test pharmaceuticals based on the capacity
of their forensic laboratories, the TruScan could be deployed to FDA
field inspectors as well as US Customs & Border Protection officers to
authenticate pharmaceuticals as they enter the country or at various
nodes in the supply chain. Given that an average measurement takes less
than a minute, a single instrument and inspector could test several
hundred samples per day, allowing a far greater proportion of
pharmaceuticals to be inspected and protecting US citizens from the
dangers of counterfeit or substandard pharmaceuticals.

Furthermore, the data gathered from multiple units across the country
(or the world) can be uploaded as frequently as desired to a central
database to facilitate tracking of counterfeits and to aid in forensic
investigations.

**Conclusion**

Ahura Scientitific's TruScan provides a means to "bring the lab to the
sample" rather than requiring samples of pharmaceuticals to be sent to
labs for identification or authentication. At a modest up-front cost and
minimal on-going costs, the TruScan could be implemented as one piece of
a layered solution to eliminate a large proportion of counterfeit drugs
from entering or circulating in the US supply chain.

Ahura Scientific welcomes the opportunity to demonstrate and discuss the
TruScan's applicability to FDA's anti-counterfeiting strategies in more
detail.

Please direct further inquiries to Julien Bradley
(<jbradley@ahurascientific.com>); (978) 642-2563.