Temperature control
heating systems, or which cool using dry ice. Passive containers are simply insulated boxes with no active temperature control. Clearly, the risk profile of the product will be a key factor in determining the nature of the packaging that is chosen, but if there is a way to offset risk using passive solutions, then they will be cheaper, more convenient and more sustainable. That said, there can be no compromise on performance in high-stakes situations like a clinical trial. “If the cold chain is not properly secured from end to end then it will compromise the quality of product, whether it is organs, blood, trial drugs, pharma treatments, specimens or anything else,” says Temidayo Akenroye, associate professor of supply chain management and analytics at the University of Missouri-Saint Louis, who has extensive expertise in cold chain management. “They are temperature-sensitive, so if the temperature goes too high it can damage molecules and expose substances to fermentation, as bacteria become active at different temperatures.” Companies invest a lot in developing new medicinal products, so if the cold chain fails, they will incur a lot of waste and increase the cost of the trial significantly. “The problem might only emerge at later stages of transportation and distribution, perhaps at the point of distribution or patient use, though damage could have happened in the initial stages of transport,” says Akenroye. And it is not only the external environment that can affect temperature. Even a vehicle hitting a pothole could agitate blood samples or novel drug therapies, generating heat. So, the external temperature could be maintained within the right limits, but agitation that excites molecules can cause damage if they are not transported in the right way. The choice of passive packaging solutions is, therefore, one that requires careful consideration.
The decision matrix
The criteria used by pharma companies to select storage containers for clinical trials must be carefully thought out, as they must balance considerations of cost and performance. The logistics process can be complex, particularly as the trend towards remote or virtual trials gathers pace. “Passive cooling is often appropriate because it comes with many advantages,” says Akenroye. “It can be used in environments where there is limited access to electricity or no grid connection at all. So, it is particularly suited for use in emerging economies, where even hospitals may not have reliable electricity.”
In some instances, pharmaceutical companies take a hybrid approach based on the climate they will be traversing to reach a trial destination. Akenroye uses
Clinical Trials Insight /
www.worldpharmaceuticals.net
vaccines as an example, which are often made in developed countries and transported to those with less resources. “So, if they develop vaccines for use in a target market such as Africa, they could use active cooling in the parts of the supply chain that are in the UK, the US or [other] developed markets, but in packaging product they will need materials to redistribute the temperature and prevent effects from external heat when they leave those markets,” he says. “The cost efficiency of passive cooling and the fact that they don’t need external electricity makes it very useful indeed.”
“Passive cooling is often appropriate because it comes with many advantages. It can be used in environments where there is limited access to electricity or no grid connection at all.”
Despite active and passive containers applying to a wide range of use cases in transporting drugs for clinical trials, there’s no such thing as a fool-proof option, as Akenroye explains. “There is always going to be a trade off,” he says. “There is no fixed option that offers the optimal solution, as it will always depend on the budget and the specifics of the trial. You could have active cooling that you are sure works, but if there is a problem with the packaging, then that problem would exist even if the product were in a freezer. There are factors that could affect the radiation of the heat, so products could be damaged even in a very cool environment.” This, of course, is why shipment monitoring is important in the transport of investigation medicinal products, and that applies to both types of container. “If you use an active system, constant monitoring of product temperature and not just the cooling environment is very important,” he continues. “You have to link monitoring processes to the product rather than the refrigeration system.” With passive cooling, the choice comes down to the environment and access to electricity, but it could also be a strategic decision based on sustainability and the desire to reduce carbon footprint. “Constantly using electricity increases carbon emissions, so passive cooling solutions could be a good tool for reducing them,” Akenroye adds.
A hotbed of innovation
Though they have many advantages, passive cooling technologies are not without drawbacks. They work by redistributing heat and excluding external heat through natural conduction, but an over-reliance on such solutions without sufficient consideration of factors other than the quality of the insulation
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