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Pharmaceutical Manufacturing and Packing Sourcer

Full Speed Ahead

PMPS: What are the main challenges of distributing vaccines at ultra-low temperatures?

Richard Wood: Getting shipments expedited quickly is always a priority. Many vaccines require shipping at temperatures below -20°C , and more recently, with one of the mRNA COVID-19 vaccines, within the -60°C to -90°C range, often referred to as ultra-low temperature (ULT). To maintain these states, highly specialised ULT parcel shippers filled with dry ice are utilised. When ULT vaccines have to stay within these parameters for extended periods, a process called re-icing takes place. Surprisingly, perhaps, one of the main challenges is to prevent vaccine temperatures becoming too cold.

The development of ULT shippers for the COVID-19 vaccine presented many new challenges. The final packaging system had to be used for commercial outbound logistics as well as storage at point-of-use sites, all at temperatures far lower than any previous vaccines. This had never been done before. Speed, flexibility, and persistence were crucial.

How well equipped are current temperature-controlled shippers?

Right now, the landscape is continually changing; we are repeatedly being asked to innovate. We have come to expect the unexpected. But it’s fair to say that temperature-controlled shippers have the bases covered. There are qualified pallet shippers that maintain ambient temperatures of 0°C to +30°C for widely available treatments. However, where vaccines are concerned, high-performance shippers operate at chilled (+2°C to +8°C), or frozen (-20°C) temperatures. The Oxford-AstraZeneca vaccine, of course, ships chilled. In the wake of COVID-19, requirements changed. Developing ULT shippers to maintain mRNA vaccines in a deep-frozen thermal state, and for long enough to act as a storage device, was new territory. The pattern was ‘design it, build it, test it, repeat’ until the shipper’s performance was perfected.

What will the lasting impact of the cold chain’s response to COVID-19 be on the industry?

The speed with which COVID-19 hit has meant we have had to respond in kind. To do that, processes have been operating in parallel with one another. You have to remember this isn’t the sort of industry where you can cut corners – there’s too much at stake. So, the ability to adhere to development and manufacturing processes, while operating flexibly within them was the only way forward.

With the ULT shipper, design and development went into overdrive. Packaging prototypes were pushed through quickly – with both laboratory and field testing. As soon as the first wave of vaccines was commercialised, we were delivering shippers with stock ready to go. Not many temperature control packaging (TCP) vendors can operate like this, but it mirrored the way the vaccine manufacturers were having to work.

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Richard Wood is Executive Director – Technical Solutions at Softbox Systems and has over 18 years’ experience of designing and engineering innovative temperature control packaging systems. Having worked in the cold chain industry for almost all his career, Richard has developed high-standard skills in searching for new and innovative ways to help clients overcome their cold-chain distribution challenges by developing market-leading products and services that meet the exacting needs of the life science industry.
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