How are Temperature Restrictions for Ambient Temperatures Affecting Packaging Design?

Jim Lucie

Jim Lucie, Senior Manager for Material Control at AMAG Pharmaceuticals, joins Pharma IQ to discuss cold chain supply and ambient temperature control of pharmaceuticals distribution. To listen to the interview in full go to Keeping the Ambient Supply Chain Cool.

Pharma IQ: Please could you tell us about your role and responsibilities?

J Lucie: I’ve been here for several years, and what I’m responsible for is both the distribution, labelling, packaging of both commercial drug and clinical trial material. Our product, we, AMAG, is a licensed product as of July, 2009, for, it’s an iron replacement therapy foranemics, specifically for patients with chronic kidney disease. Our drug is an ambient drug, a control room temp, though we do have a pretty wide stability range, but we do ship and do long-term storage under control room temp.

Pharma IQ: What current challenges are you finding associated with ambient control supply?

J Lucie: A lot of our challenges, at least for our product, is on the, more on the cold side than on the hot side. With trying to maintain the 15-30 long-term storage, and a little bit wider range on the shipping side, we find, when it goes, like this past winter was a rough winter, both in Europe, when we were doing our clinical, and here in the States for our commercial supply, was, we were getting some freezing, and that’s sometimes associated with either the air portion of the freight, or sometimes the longer drives, sitting in the back of a UPS or a FedEx van. We were getting low-temperature experience more than the hot side. Seems that, , the packaging seems to be fairly decent sometimes at protecting from the warmer, but the cold side seems to be more of a challenge.

Pharma IQ: Do you think that the financial crisis and current climate has affected temperature control supply and ambient control supply? Have there been any trends that you’ve noticed?

J Lucie: Not for us that I’ve noticed. We’ve been doing okay there doesn’t seem to be any real, like, additional delays, or, , room on flights or things like that as a result of this, or, say, , or cutbacks in certain areas, at least from what we’ve been seeing. We haven’t really seen an effect on the product or on our distribution.

Pharma IQ: On a wider scale, what trends are you currently seeing in the supply chain landscape?

J Lucie: Seems like the industry has a pretty fair grasp or handle on how to do a two-to-eight shipment, or even the dry ice shipments. It seems to be more focused now on the CRT portion of it as drugs come off of a two-to-eight and they try to get a wider range for shipping and storage, which just makes it easier for the supply chain itself, from a drug standpoint, but it seems like there’s a new focus on control room temp from the shippers, and a little bit closer look at that even from a regulatory standpoint.

Pharma IQ: With control room temperatures there are more stakeholders involved, for example doctors and patients. How do you think we can educate the industry, stakeholders, patients, to understand the importance of ambient control supply?

J Lucie: I think just trying to maybe be more descriptive on the, either on the carton or on the patient insert, , that comes along with the drug. One thing I noticed which I think, and maybe not enough people take advantage of, is having more of a dialogue, or a talk, , if you would, on the, on the description. Not just keep the thing between, keep our drug between 15 and 20 or 15 and 25, but have a little bit more descriptive. If you’re shipping it, we, you can do this temperature; if you’re going to be using it, you can do this temperature; it can sit on your counter for this long. I think one of the companies that presented or talked last year had a much more descriptive, more commentary, or day-to-day language of how to handle the drug in different instances to make it easier for either a doctor or a patient to decide whether or not they have a problem.

Pharma IQ: At what stage do you think that the drug development team should start getting marketing, sales, and supply chain involved?

J Lucie: I think as early as possible, even when you’re doing your initial stability protocol, or your stability program design. Again, taking into account, or having both the marketing people in as they’re describing, or just trying to figure out how to package, label, what is it going to look like, either on a shelf, if it’s an over-the-counter or a commercial drug store type product versus a hospital-only product, and then same with the supply chain. Again, understanding, for those people developing the stability side, understanding how the drug is going to be shipped and stored and how it’s going to be handled after it’s been developed and approved, I think, is important so that you’re not scrambling at the back end, think, oh, well, now we need a new stability programme, or another profile to cover something that we didn’t think of earlier. I know that’s something that we as a company had to go back and do and look at some different temperature ranges once we understood better, or once people, , back in the research and development side understood better of how the product actually moves from the factory to the patient.

Pharma IQ:
How are temperature restrictions for ambient temperatures affecting packaging design?

J Lucie: That’s a good question. If you’re looking for something that is going to be more user-friendly for someone who’s buying it at the drug store site, if it has to be kept colder, or kept in a certain way, it may not be, may not be the best way to market the drug, so I think that those types of considerations should be made.


Interview conducted by Andrea Charles

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