Temperature control
for the sake of timing. They want the product available and with patients as soon as is feasible to progress the study.” On the other hand, if trial organisers are transporting products in two locations on the same continent, mainland Europe for instance, Peck says the specialised courier services they employ are more likely to use land and sea vehicles.
Down to size
The other key determinant of whether to send products by air is the size of the cargo load. In commercial pharmaceuticals, it’s the norm for pallet-sized shipments to be onboard in their hundreds. The average sea-freight vessel can carry 15,000 shipping containers, each with around 20 pallets inside. On the other hand, due to the shape and size of most aeroplanes, all but the most specialised aircrafts would struggle with a single container. This ability to carry so much cargo comes with obvious cost benefits – when supply outweighs demand, prices drop. It’s a major reason that ocean freight has been growing in use in recent years, with one forecast from PharmaLogisticsIQ predicting that 75% of pharmaceutical payloads will be transported by sea in 2028, up from 20% in 2018 when it made the call. But it’s also this size and capacity advantage that disqualifies ocean freight as the transportation choice for a lot of clinical trial products. “If you’ve got two or three shippers that are no bigger than my tiny little desk here, you’re not going to put those in a reefer container,” he says. “Air freight is the only option.” It’s not just the method of transportation that’s determined by the size of the shipment either. In all industries that rely on cold-chain logistics to keep their products at a safe temperature, there’s a decision between active and passive containers – active being containers with electrically-controlled cooling, while passive are insulated boxes with no active temperature control. “Active is for pallet-sized shipments and above,” says Peck. “With clinical trials, you could have two boxes that are 400x400x400mm; you’re not going to put those on a pallet inside an active container, so you’d use passive.” With this example, Peck highlights an issue with the available range of containers on the market, at least as they pertain to clinical trial supply. “Even the mainstream, reusable, or advanced passive as we seem to refer to them, containers, are still designed for commercial, pallet-sized shipments,” he says. “It goes back to that volume size. Less than container load, or LCL, is not really a widely-used service in pharmaceuticals.” Instead, those in charge of drug supply for clinical trials must opt for the
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best fit, and that’s not the only area they can be forced to make compromises. “With commercial, you kind of know your lanes,” says Peck. “There’s an expectation that I’ll have mapped out my lanes and I’ll understand the legs within [the journey], the expected times each of those legs will take and the potential temperatures within them. You may not have that level of detail with clinical trial materials.” This, he adds, means that whereas a supply chain professional would map out their journey, factor in the potential risks and then choose a suitable container, those working on clinical trials will have to take a belt and braces approach because they don’t have that level of detail on the risk profile of the shipment. “It might be a little more ‘okay, I need a solution that I know is going to be good for five days or beyond’,” he says.
Cargo planes have much smaller containers than the large metal ones carried on cargo ships.
“If you’ve got two or three shippers that are no bigger than my tiny little desk here, you’re not going to put those in a reefer container.”
Running a temperature One aspect of the supply chain that doesn’t change regardless of whether products are going to commercial customer by sea or a clinical trial site by air is exactly how the temperature is controlled within a passive container. In both cases, the key is phase-change materials (PCMs) – paraffins, fatty acids and alcohols conditioned to a set-point temperature where they are able to reliably store and release energy to maintain ultra-low temperatures inside a container.
In certain instances, water is used as the PCM to save on cost, but Peck says the value of clinical supplies is much too high not to opt for a more
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