Temperature control
can lead to increased risk. “People often trust that the packaging will maintain temperature based on humidity and radiation, but there are contextual factors like agitation that could create heat and affect efficiency of passive cooling,” notes Akenroye. “There are various solutions and techniques out there, and they promise many things but there are instances in which these claims cannot be totally relied upon.” It’s for this reason that Akenroye tends to advocate the use of both systems. “This approach has been used in research trials, including some related to Ebola treatments – where all of the reagents came from the US – where active cooling was used. But as soon as the product reached Benin, it had to rely on passive cooling,” he adds. A hybrid approach optimises quality control, energy use and cost, but it won’t eliminate all the risk. For that reason, there is a constant process of innovation to improve not only the energy efficiency of active cooling systems, but also the performance of passive cooling solutions. In 2019, space cooling accounted for almost 9% of total final electricity consumption, equal to more than one gigaton of carbon dioxide emissions. This statistic set researchers at the Massachusetts Institute of Technology (MIT) on course to develop a new passive cooling system for buildings, the principles of which could impact the way the clinical trial cold chain functions in the future. The solution, which requires no electricity, resembles a solar panel and consists of reflectors, evaporators and insulation layers to create a cooling effect as water and heat pass through the device. A sponge-like hydrogel layer is immersed in water for evaporative cooling. “There
is a lot of innovation happening, and at MIT there is rigorous innovation and research into materials to help with the redistribution of heat and use natural conduction to cool a product,” says Akenroye. “There is also research happening at other institutions, including Albany University, which has developed a type of ice that not only takes longer to melt, but also reduces the likelihood that bacteria will form.” With many options for insulation and packaging on the market, Akenroye’s experiences have led to him advising most companies to test them before use. “Do a pilot scheme to trial different systems,” he says. “I worked with the NHS in the UK for many years, and we did pilot projects for four-to-six months using all solutions from a supplier, so that we could compare different solutions and choose the best one for each application.” Another consideration when organising the supply of clinical trial drugs is whether it’s worth taking a risk-sharing approach by involving a third party with expertise in the area. “One way to manage risk is to use contractual terms and conditions with a solution provider,” says Akenroye. “I would want to guarantee 100% preservation of temperature for the required duration of the journey, and I want to be able to hold the solution provider accountable for that. The risk mitigation strategy can be in the contract, and if a supplier says no to that then you should have some suspicions right away.” There’s a lot of innovation going on to improve the state of passive cooling, but for clinical trials, maintaining the integrity of investigational medicinal products will continue to be a shared responsibility of balancing cost, sustainability and quality control. ●
Dry ice is a common material used to actively cool pharmaceutical products while they’re transported.
34 Clinical Trials Insight /
www.worldpharmaceuticals.net
CornelPutan/
Shutterstock.com
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