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Manufacture Advanced Medicine, Supply Chain

Logistics Will Prevail

It might be hard to imagine a world where cell and gene therapy manufacturing and logistics is fully standardized with little human intervention – all at a reasonable cost. But prior to the 1980s, who could have imagined that it would be possible to ship biological samples across the globe to carry out clinical trials? I think the story of World Courier nicely illustrates how logistics evolves to meet the demands of industry – especially pharma. 

Let me take you back to 1969, when James R. Berger, a grain broker from Downtown Manhattan, founded World Courier. He knew that his industry needed a means of rapidly shipping documents to various international points to arrange overseas shipments of grain. The US postal service would take three weeks, even with a first-class stamp. So Jim decided to ship documents on commercial airline flights – and hence World Courier was born.

Cell and gene therapies are different because the logistics are built into the manufacturing process – and the patient is part of the process.

Over time, the company built a global network. And by the 1980s, the pharma industry had started large infectious disease trials, involving central labs where samples had to be shipped to and from, globally. World Courier entered the biopharma industry to facilitate these trials, eventually moving into the commercial space. This required innovation in cold-chain technologies to ensure that products could be maintained at the right temperature.  

Later, as an increasing number of trials were being carried out at academic hospitals, it became apparent that product was being wasted due to the large variations in patient recruitment – couriers were always oversupplying. In response, World Courier created in-country clinical storage depots so that we could respond to variations in patient recruitment quickly, which then evolved to store commercial product – so that changes in demand could be met.

Today, we’re seeing another huge change with cell and gene therapies. We now have autologous therapies, where patient material is shipped to a manufacturing site and then returned to the patient – all within two to three weeks. A central challenge is that you can’t be too early or too late. With traditional therapies being delivered to a hospital, you have quite a large window, but when you’re delivering a CAR-T, for example, nurses (who will receive the therapy to ensure the integrity of the product: making sure the temperature stays within range) will only have specific time-slots. The same goes for the manufacturer, who will have all of their slots planned out in advance. Miss, and you lose a very expensive therapy and, potentially, a patient's chance of life. 

In the past, therapies would be developed and the logistics would be sorted out later – there would be a hand-off to a completely separate infrastructure. Cell and gene therapies are different because the logistics are built into the manufacturing process – and the patient is part of the process. 

There’s plenty of room for improvement. Greater standardization of procedures is sorely needed, for example, as different companies have developed their own ways of delivering these therapies during the development process. In my view, we also need new capabilities in cryogenic storage and technologies to track chain of identity and custody – and new solutions in this area are starting to emerge. 

How can we make this vision a reality? The key is for manufacturers and couriers to collaborate much earlier in the development process. Just as quality by design has become a key feature of pharmaceutical manufacturing, so too must logistics by design. There’s great value in making an early decision on the manufacturing and logistics process, such as how many sites are you going to have? What sort of packaging are you going to use? And where are you going to charge your packaging? Couriers can advise on these things and, at the very least, supply some data on the implications of decisions on future costs. For example, if you have dry shippers that can only be charged at set points around the world, then you’re automatically adding a leg to your logistics process. And more legs means greater costs and potential quality problems, especially when manual hand-offs are involved. Alternatively, you might choose to leverage technologies where you can charge at a courier’s office. There’s no right or wrong answer; it’s about understanding the implications of your decision early, so that you don’t face any unexpected challenges later on. 

It’s incredibly exciting to see new therapies coming through, but there’s a lot that we, in collaboration with manufacturers, can do to improve safety and efficiency – and ultimately bring down costs. But if history has taught us anything, it’s that innovations in logistical technologies and processes will evolve to facilitate the delivery of new therapies.

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About the Author
Sam Herbert

President of World Courier.

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