As the drug product security landscape broadens, many manufacturers are looking beyond packaging-level security features and looking for ways to secure the actual drug product itself. Advances in “on-dosage” technologies have made them feasible complements to tamper-resistant packaging, barcoding and other traditional security features.
NanoGuardian (a division of NanoInk, Inc.; Skokie, Ill.) has been at the forefront of the on-dosage movement. Pharmaceutical Manufacturing recently spoke with Dean Hart, the company’s executive vice president, about current challenges and market opportunities.
PhM: For those who might not be familiar with the company, tell us a little bit about the genesis of NanoGuardian.
D.H.: Certainly. The company really started about seven years ago as NanoInk, and the genesis of the company really was the focus on a proprietary technology dip pen nanolithography, or DPN. This technology was perfected through an alliance that NanoInk has and continues to have with Northwestern University School of Nanotechnology, one of the foremost leaders in the field of nanotechnology. And the key behind that was really the ability to take and place molecules ... on predefined substrates within a given pattern. And it has the greatest application within research and development.
And at that point in time, individuals within the organization, many who had a strong pharmaceutical backgrounds, realized that the R&D component of our DPN, which is still very, very strong for us, was just one application where this incredible technology could be used, and so given their experience in pharma, and given the increasing concerns over counterfeiting and illegal diversion, looked at the ability to take that technology at its basic level and really evolve it into something that could be used to help manufacturers and authorities fight counterfeit medications and illegal diverted products. So over about four years of R&D on our part, we have now come up with what we term a nanoencryption technology, and we’ve perfected our technology.
And basically, at the simplest, to kind of dumb it down, this technology applies directly to tablets, capsules and vial capsules. We are on-dosage technology, and we have a multilayered security feature, so we have overt and covert, which are used more on the authentication side and the counterfeit side of things. But then, at the deepest level of our technology is the forensic level, which is the nanoscale level. We place what we call nanocodes on dosages, on tablets, capsules and vial lids, and these nanocodes can be associated with an unlimited amount of information, both manufacturing data such as manufacturing date, location, batch, lot, strength, expiration date, as well as distribution data such as what specific country was this distributed in, and even to the extent of which particular distributor or wholesaler or retail chain, if you will, should the manufacturer determine that to be the case.
PhM: If you don’t mind, let’s break this down in terms of some of the things that you’ve just brought up. Explain a little bit more about what nanoencryption technology is and what it actually means to put a nanocode on a dosage, say, for example, a capsule, a tablet. Tell us as much as you can without, obviously, sharing too much with counterfeiters and your competitors.
D.H.: [Laughs.] Certainly. ... First and foremost, we add nothing to the dosage. We add no chemicals, we add no additional product, if you will, to the particular medications that we’re encrypting. What we do is we have perfected a manner by which we make manipulations in the coatings of those tablets and capsules and vial caps, and by doing so, we’re able to, at a very high throughput — over a million encryptions per eight-hour period — be able to place our multilayered security features actually on the dosage. So manufacturers like it, and the fact that because we’re not adding anything, the development required and the regulatory requirement work that needs to be done is significantly minimized. ...
PhM: So it’s a feature that’s on the surface of the dosage?
D.H.: It is on the surface of the dosage, exactly. And our nanoencrypter machine ... typically sits within the manufacturing line right before packaging. So the product is complete, it goes through our nanoencrypting, we place the nanoencryption codes and the other security features on the dosages, and then they go into the appropriate packaging.
PhM: And then how is the data read, and where would it be read if a manufacturer had your technology?
D.H.: There’s three different layers of security features. The first feature is an overt feature, and that can be seen with the human eye. We actually call it semi-overt, because if you didn’t know what you were looking for, you wouldn’t see it. But if you did, you would know that this particular medication or particular dosage had been encrypted. And the second layer is a covert feature. Now, both of these, the semi-overt and the covert, are used for authentication at the field level. And from that perspective, let’s say a manufacturer or a pharmacist, would be able to either use a loupe or a handheld microscope, 40x microscope let’s say, and be able to see the secondary forensic — excuse me — covert security feature, which is actually at the micron level, and be able to determine that this is an authentic tablet.
Now, the third feature is where our nanocodes come in. And because we are at that nanoscale level, there’s really nothing, from a handheld perspective, that can be used to read that. And that’s seen by our organization as well as my clients as a good thing. And where we do that is at our NanoGuardian Authentication Center, the first of which has been established here in Skokie, Illinois, right outside of Chicago in our home office.