Temperature control
Dry ice is the phase- change material most commonly used to maintain a temperature of 2–8°C, which the majority of drugs are kept at during shipping.
reliable solution that can endure temperature excursions. “Even if it’s subjected to extreme temperatures for short periods of time, all that does is melt the PCM, or sublimate the dry ice, a little bit quicker,” he says. “Your product is okay because it’s protected, but if you leave it there for hours on end, you’re reducing the time for which the shipping system will perform.” In the case of higher-risk products, like cell and gene therapies (CGTs), containers might be topped up with dry ice or other PCMs, but this is something that specialist couriers and the contract research organisations (CROs) that often take control of the supply chain as part of an outsourcing agreement are acutely aware of, adds Peck.
Eyes on the monitor
The area Peck does see the potential for progress, no matter what means a product is travelling by, is in the monitoring of shipments. “Most clinical trials that I’ve observed are still using the traditional passive monitoring with USB technology,” he says. The alternative method he expects to see gain ground within the industry, especially as the number of CGTs in trials increases, is real-time monitoring. This, Peck argues, could be especially beneficial in the early stages of a clinical trial. “Your knowledge of how stable the product is at the clinical trial stage, particularly phase one and two, is a lot less than it will be by the time you come to commercialising it,” he says. “This means any temperature excursion can be a challenge. But if
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, there could be less of it used if it’s only topped up when necessary – as determined by a real- time monitoring system – and so, less of it reverting to its gaseous form and accumulating in the Earth’s atmosphere. There are, Peck says, containers designed for air and sea which have recently come to market promising a slower rate of sublimation, long- term reusability, and technology embedded within that allows for real-time monitoring. But much like their counterparts, they’re designed for the commercial market, so the jury is out on how applicable they will be to newly investigated drugs. Cold-chain innovations like these so-called advanced passive containers tend to reach the field of clinical trials later than they do the commercial side of pharmaceuticals, but with so much buzz around CGTs, real-time monitoring could be the next technology to add meaningful value to the sector, whether products travel by land, air or sea. ●
we can see something is going wrong [in real-time], we may have the potential to intervene.” With this style of temperature monitoring, shipments can be spared the risk of excursions when they’re opened to check the number on the USB device, or to pre-emptively top them up with dry ice. Excursion data collected in these early trial stages could prove to be extremely valuable for understanding more about the cold-chain requirements of investigational medicinal products and designing appropriate standard operating procedures (SOPs) for when they’re transported on a larger scale. As a related benefit, with dry ice being the solid form of CO2
Clinical Trials Insight /
www.worldpharmaceuticals.net
Elzbieta Krzysztof/
Shutterstock.com
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