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The UK is in the midst of an imminent CO2 shortage crisis.1 While a deal has been brokered2 to maintain supplies through January, decision-makers have yet to create a permanent solution. This is the second time in less than a year that CO2 shortages threatened critical cold chains.3 CO2 is the main ingredient in dry ice, but also serves many other functions, particularly in the food supply chain. Should this shortage continue and eventually spread beyond the UK, it has the potential to residually impact the medical supply chain in the midst of the continued global COVID-19 vaccination campaign. mRNA COVID-19 vaccines still require ultracold temperatures (typically -20°C to -86°C) for longer term storage and many logistics providers rely heavily on dry ice to accomplish these deep-frozen temperatures.
This crisis not only foreshadows future challenges for resource sharing between these critical industries, but also illustrates the drawbacks of any limited resource—there’s simply not enough of it to go around. As the global population rises and the life sciences industry prepares to deliver more mRNA-based and precision medicine treatments, which will also require ultra-low temperature (ULT) storage, both industries’ need for this resource will only grow. Fortunately, permanent infrastructure can address growing ULT storage needs while mitigating the need for dry ice in healthcare and research. When considering whether permanent ULT infrastructure would be a more suitable option than ongoing dry ice procurement for cold storage, look to the following key points:
While dry ice can maintain an ultracold temperature range, whether it can keep products thermally protected at the exact desired temperature setpoint is subject to careful handling by trained personnel. Dry ice also has a shortened lifespan; it is estimated that 10 pounds lasts about 24 hours in a standard 25-quart cooler.4 Once it begins to sublimate, dry ice must be replenished to keep products at their specified temperatures. However, if a product is stored for long periods of time, such as a long-distance shipment, its container will need more frequent replenishment. For instance, when the Food and Drug Administration (FDA) authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use, the Centers for Disease Control and Prevention (CDC) recommended that it be stored at ultracold temperatures. Thus, the vaccine thermal shipping containers were to be replenished with dry ice every five days or less to prevent spoilage.
Furthermore, an analysis conducted by the CDC reported that over 15 million COVID-19 vaccine doseswere tossed out from March 1 to September 1 in the US.5 While the reasons were not stated, vaccine spoilage due to missed appointments could certainly be a primary cause. In April alone, millions of Americans were reported missing or delaying their second vaccine dose.6 This underlines the need for permanent infrastructure to enable ongoing vaccine preservation, as the lifespan of ULT storage averages 12 years.
Consequently, setting up permanent ULT storage at the administration and receiving sites guarantees a longer product shelf life and is much more stable and dependable than dry ice replenishment with a local gas company. As stated above, ULT storage is not subject to the vagaries of patient schedules and missed appointments that clinics and cell and gene therapy (CGT) treatment providers must constantly be prepared to address. Considering the ultracold storage requirements of biologics and CGTs, ULT freezers can also provide the long-term storage needed to preserve the integrity of these medicines.
The adoption of biologics and CGTs has accelerated in recent years, driven by scientific and technological advancements in precision medicine. These new treatments are unique, one-of-a-kind, small in volume and high value—not only in cost, but by the very essence of life and death for the patient. If spoiled, the results could be fatal. With the FDA decreasing drug-stability testing requirements to authorize emergency use of medications, these now have stricter storage requirements and must be kept at specific cold temperatures when traversing the cold chain of custody. And, with some ULT freezers now offering wider temperature ranges, the ability to accommodate a broader range of treatment assets at multiple stages of clinical development enhances the return on a permanent ULT investment.
However, dry ice is prone to temperature changes as it sublimates, and such inconsistencies could destroy the efficacy of vaccines and therapies. ULT freezers are a far more reliable option, as they can consistently control temperatures throughout the cabinet. Additionally, ULT freezers can be “dialed-in” to a specific setpoint temperature and perpetually maintain that temperature. This helps repurpose freezers when the immediate need is completed, as some ULT freezers can be set anywhere between -20°C and -86°C. Unfortunately, this is simply not an option when cooling treatments/biologic assets with dry ice.
For organizations dealing with stringent temperature requirements and sensitive materials, an accurate and efficient storage option, such as permanent ULT freezers, may be best. However, for those with products that are less temperature-sensitive or only need short-term storage, dry ice could be an alternative option.
CO2 is a byproduct waste from the burning of fossil fuels, but the amount that can be captured and recycled into dry ice is limited. Dry ice sublimates into CO2 as it releases energy back into the atmosphere, therefore it is not a directly cyclical renewal process. It does have its benefits, such as providing cold storage for temperature-sensitive food and beverages, but when it comes to products like pharmaceuticals, dry ice may not be the safest or most sustainable option.
While dry ice itself is not harmful to the environment, it requires significant energy consumption for its creation and storage. Furthermore, if not handled or disposed properly, it can create exceptionally hazardous effects for people and animals nearby.Instead, ULT storage providers that are sustainably sourced, such as those that are ENERGY STAR®-certified with high ratings on energystar.gov,7 can contribute greatly to companies’ green initiatives and are a much safer alternative to dry ice. Many ULT freezer providers also use natural refrigerants, which are far less depleting to the ozone layer than HFCs, while reducing overall carbon footprint.
As another potential CO2 shortage emerges, it’s crucial that this resource only be used where absolutely necessary. The demand for COVID-19 vaccines, mRNA-based therapies and precision medicine treatments will only continue to grow, and organizations will have to rethink their ULT strategies to prevent CO2 shortages from impacting the pharma cold chain. Fortunately, the above points can help companies determine whether permanent ULT infrastructure is more appropriate for their ultracold storage needs.
Shea Vincent is Senior Marketing Director at Stirling Ultracold.