Pharma - Bio Transport - February 2008

Feature

“RFID chip could potentially even track temperature,” he says. “If pedigree is put in place using RFID, the technology could also be used to track temperature in transit.”

This prospect raises exciting possibilities in terms of cold-chain streamlining. “Imagine treating yourself at home, and you have an RFID scanner,” Sinclair says. “You get the product from the pharmacy, scan it right there,” and determine whether you received the correct drug and whether the drug stayed within the manufacturer’s stated temperature range. No one’s holding his breath, however, as adoption of the technology has been slowed by concerns over cost, standards development, and the impact of radio waves on proteins, Sinclair points out.

As Ames notes, all links in the supply chain need to collaborate for the greater good, but in the United States at least, ultimate responsibility for product safety rests with the pharmaceutical manufacturer. In his position as director of marketing and business development for packaging company Tegrant Corp./ThermoSafe Brands (DeKalb, IL), Richard Ellinger has observed that 3PLs “are taking more responsibility when handling the repackaging end of the business because the 3PLs are following the lead of the manufacturers.” He notes that USP’s General Chapter <1079> requires shippers and distributors “to follow the proper storage and shipping requirements, as indicated by the manufacturers.”

ThermoSafe’s mail-order fulfillment customers, in particular, have shown increased interest in pursuing opportunities in the 3PL space, Ellinger says. He adds that the company’s business has seen “nothing dramatically different from what we’ve faced in the past.” However, in terms of ThermoSafe’s market, he notes that the company services pharmaceutical and biotechnology manufacturers “the same way we service the 3PLs, because their needs are more similar than they’ve ever been before.”

Those needs involve a high level of complexity, says Rob Brown, vice pres-

ident of specialty sales for Cardinal Health (Dublin, OH). Cardinal Health’s 3PL division, special pharmaceutical services, has “ 17 clients selling therapeutic biologicals requiring cold-chain distribution. “The key thing that presents difficulty in the cold chain, more than product characteristics, is the delivery requirement,” he says.

Cold-chain products stored with a wholesaler “may have 20 days worth of inventory, and if they go through wholesale channels, the requirements are complex,” Brown says. “The more-complex need is shipping directly to a physician’s office for a scheduled administration. Some clients get orders at

Changes in the regulatory

climate are also putting some

heat on the industry. Regulators

worldwide have expanded

the definition of a

temperature-controlled

product, Orfanos says.

10 A.M. on Monday that need to be shipped overnight because at 11 A.M. the next day the patient is showing up for administration.”

For a 3PL transporting products to a wholesaler, “it is a very expensive piece of the cold chain,” Brown explains. “Most everything goes overnight in cold chain, so you’re mostly shipping UPS or FedEx parcel shipments. If it’s a biotech [product] the volume is not as high as traditional [drugs], so you’re spending a lot of dollars in overnight shipments versus Less-Than-Truckload (LTL) shipments.”

However, Cardinal Health believes there are plenty of opportunities to consolidate transportation because its 17 cold-chain clients “pretty much ship to the same people,” Brown says. “We think there’s an opportunity around consoli-

dating the transportation to those similar customers.” Counting the cost of validated shippers, overnight transportation costs, and conversion to truckloads, consolidation could be up to 15–20% less expensive, Brown says.

Brown says a 3PL can usually limit liability exposure if it follows the manufacturer’s quality assurance instructions defining “the packaging configuration. As long as we follow that configuration, we’re not liable.” Causing a product to freeze by putting it in a gel pack for shipping when the customer’s SOP calls for an ice brick is an example of a lapse that could lead to the manufacturer filing a liability claim with the transportation provider, he says.

Variability is most common in the transportation link for 3PLs, Brown notes. Studies by companies such as Sensitech “show what happens when product goes up in a plane. It is amazing the variance of temperature in the hulls of those planes,” he says.

Reducing those variables and decreasing the number of handoffs will mitigate product risks, asserts Donald Nolde, vice president of sales and marketing, Cold Chain Technologies (Holliston, MA). “The fewer people handling product, the better off you’ll be,” says Nolde, whose company specializes in cold-chain shipping containers. “We have seen the need for third-party logistics increase over the last few years, and I believe that will continue with the biotech sector. Our task at Cold Chain is to make their job easier and with better compliance by providing improved and simplified packaging solutions.”

Says Nolde: “We’re focusing on the fact that at the end of the day, whether you’re a 3PL, or a pharmaceutical manufacturer, or a biotech company, it’s your responsibility to ensure that small molecule or large molecule [products] arrive in unadulterated and safe condition. I’ve got two daughters. Do I want them to receive a drug that’s not in good condition? Obviously, I do not.”