Clinical supply & logistics Cooling the O
ver the years ahead, the pharmaceutical cold chain industry will have a mammoth task on its hands. For one thing, supply chains are becoming more complicated. With drug production frequently being moved to emerging markets, far away from the end users, the cold chain may involve long journeys and multiple transport modalities. Potentially, this comes with a higher risk of temperature deviations. The molecular makeup of drugs is changing too. According to IQVIA, drugs requiring cold chain storage and distribution comprised 26% of the pharmaceutical market in 2017. By 2022, it was 35% – and with over half of new medicines falling into this bracket, that proportion is likely to grow further still. Of particular note are cell and gene therapies, which need ultra-frozen storage (at -180C and -80C respectively). This is far lower than the 2–8C that most drug products require. Against this backdrop, we are seeing strong demand for cold chain services that can reliably
cold chain
With the push to go green showing no signs of stopping, what are the latest technological advances and systems in the cold chain industry that should be on everyone’s radar? How can businesses align market growth with saving the planet? Abi Millar investigates, speaking to Tom Rose, SVP of clinical trial sourcing at Clinigen, along the way.
preserve the medicine. Quality will always be the top priority for the cold chain industry, driven by good manufacturing practice (GMP) and good distribution practice (GDP) guidelines. Unfortunately, ensuring quality may sometimes clash with another big imperative – to keep driving towards sustainable goals. Take the expanded polystyrene (EPS) containers that are traditionally used for deliveries, in conjunction with frozen gel packs. While highly effective, this solution is wasteful as the containers cannot be reused. “It’s often very possible to comply with GMP while being sustainable,” comments Tom Rose, SVP of clinical trial sourcing at Clinigen. “However, the issue is keeping the cost down. We need to use emerging technologies to keep down the cost of supplies, so that manufacturers are incentivised to make more sustainable materials without putting the cost onto the patients. And the same goes for GDP – going forward we must comply with an eye on reducing our carbon emissions.”
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Clinical Trials Insight /
www.worldpharmaceuticals.net Clinical Trials Insight /
www.worldpharmaceuticals.net
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