Temperature-sensitive cell and gene therapy: the critical role of pre-conditioned packaging

While the temperature-sensitive nature of biologics is nothing new to those working in the industry – the topic has gained global attention with the roll-out of several COVID-19 vaccines. The news has widely covered how each has its own temperature profile. Some must be stored in ultra-low temperature freezers to maintain -70ºC or kept very cold at -20ºC, while others need only be held in standard refrigerated temperatures – 2 to 8ºC.

What these vaccines and other biologics do have in common, however, is that whatever the proper temperature range is – it must be maintained as it is moved from manufacturer to distributor to administration sites to ensure it remains effective. To achieve this, temperature-controlled shipments often require the use of specialized Vacuum-Insulated Packaging (VIP) shippers.

These VIP units are also used to safely move cell and gene therapies, which can be more time- and temperature-sensitive than other types of drugs. That’s because these shipments typically involve the transport of either cryofrozen or living cells, making speed and temperature even more important.

The intricacies of cell and gene therapies

Over the last decade, gene and cell therapies have shown promise in treating a wide range of rare and life-threatening diseases. In fact, according to the Alliance for Regenerative Medicine, there were more than 1,000 CGT clinical trials in progress worldwide at the end of 2019. This includes allogeneic therapies, which can be manufactured in large batches, from unrelated donor sources, as well as autologous and personalized vein-to-vein therapies. Regardless, timing and temperature are critical for both – and any break in the cold chain could be life-threatening for the patient. That’s why the packaging used to transport these therapies is so essential.

The packaging matters

VIP shippers are pre-qualified to hold a particular temperature for a certain volume over a specified period of time – 24, 72, 96 or more hours. That means using phase change materials and/or liquid nitrogen dry shippers can create an environment that ensures 99.9% of shipments stay within the proper temperature range, effectively protecting the integrity of the therapy. These shippers often also have reverse logistics, so they can be returned to the shipper, stored and reused.

It’s important to note the packaging used to maintain temperatures must be conditioned based on manufacturer specifications for the therapy being transported. This can add extra time to the process, which most cell and gene therapies do not have. Specialized warehouses help solve this problem by storing conditioned VIP or dry vapor shippers so they are always on hand and ready for use.

VIP conditioning facilities

To ensure VIP shippers are available to customers on a just-in-time basis, QuickSTAT currently has a global network of 42 conditioning warehouses around the world. As a result, we already provide the fastest turnaround times in the industry. As the investigation and use of cell and gene therapies continue to grow, however, the company is expanding its capacity to better serve the global needs of customers.

For instance, QuickSTAT recently doubled the size of its warehouse and conditioning facility in Belfast. Originally opened in 2016, this facility has seen significantly increasing demand. The move will help us meet the rising needs of our customers in particular and the cell and gene therapy industry in general. Since Ireland remains in the EU, the Belfast location will also allow us to move shipments throughout the country as well as into the EU without the added customs requirements resulting from the Brexit trade agreement.

The expansion of the Belfast facility is part of a larger growth strategy with plans to add 11 conditioning facilities throughout APAC and EU in 2021. This includes a new state-of-the-art JFK Control Tower, which will more than double QuickSTAT’s conditioning capacity to support the company’s Chicago Cell & Gene Therapy and Miami Direct-to-Patient Centers of Excellence. QuickSTAT will also co-share space in Kuehne + Nagel’s Singapore facility, allowing us to offer a more extensive catalogue of reusable temperature-controlled shippers across the region. All the facilities will use our VIP Inventory Management system, an end-to-end solution for managing, conditioning, transporting, tracking, returning and recycling inventory.

Our conditioning warehouses are also GDP-compliant and incorporate best practices in cold chain management. According to Cyril Leger, Executive Vice President for QuickSTAT, the company is committed to providing innovative and customized solutions to the life science industry. “By continuing to expand our global footprint to locations of strategic importance, we are able to support the growing temperature control needs of both Kuehne + Nagel Pharma Chain and QuickSTAT clients.”