Rethinking biological sample storage: Navigating nontraditional temperatures
Maintaining the appropriate storage temperature for biologics is crucial to preserving their integrity for downstream applications. However, as these materials grow more complex and with their increasing sensitivity to temperature fluctuations, the industry is seeing a rise in requests to store biological products at nontraditional temperatures. This trend was greatly exacerbated by the COVID-19 pandemic, which not only pushed the boundaries of biologic storage logistics but also introduced complex new modalities, such as mRNA vaccines, that often require ultracold or nonstandard storage conditions. Here we explore the reasons behind this shift towards nontraditional temperatures and the challenges it presents.
Traditional storage temperatures of biological samples
Numerous factors influence the temperature conditions of biological materials across the supply chain. To meet stringent quality standards, stability testing is conducted at various stages, including during collection, storage, inventory management, packaging, and transportation. These tests ensure that neither the process nor the equipment negatively impacts the material’s efficacy.
Historically, the traditional storage temperature for biological materials has been –80°C, with a permitted variance between –70°C and –90°C. For cryogenic materials, the storage range typically falls between –150°C and –196°C. However, there's been a noticeable uptick in requests to store materials at temperatures outside of these conventional ranges, especially noticeable from the COVID-19 pandemic.
The shift toward nontraditional storage temperature requirements for biologics
As technology continues to advance, process development and stability testing throughout drug development have become increasingly specialized. Clients are now conducting more precise tests to determine the exact temperatures at which their materials begin to lose efficacy. For example, a stability test may reveal that a biological product loses efficacy if stored below –35°C. In such cases, the ideal storage temperature would need to be around –30°C (±5°C), presenting a challenge since most storage equipment is not designed to accommodate such specific temperature requirements.
Equally important is stability testing of the storage containers themselves. If a container, such as a bag or vial, is not compatible with the specified temperature, it could become brittle, potentially leading to a loss of the material. The COVID-19 pandemic underscored the importance of such precision. The rapid development and global distribution of mRNA-based vaccines highlighted both the value and the difficulty of maintaining cold chains at nontraditional temperature ranges.
Overcoming the challenges of nontraditional temperature storage
Although storing biological materials at nontraditional temperatures presents challenges, it is entirely feasible with the right equipment and processes. By modifying existing equipment and utilizing creative configurations, it's possible to meet specific temperature requirements. However, this often requires the development of new testing protocols, which can increase time and costs. Additionally, such reconfigurations can impact storage capacity. For example, internal studies have shown up to 20% loss in capacity when modifying freezers to accommodate nontraditional temperature ranges, meaning additional equipment may be needed to handle the required volume of materials.
The COVID-19 pandemic also revealed the disastrous effects of a weak supply chain, particularly for specialized cold chain components like ultralow temperature freezers, dry ice, and temperature-controlled shipping materials. Facilities that lacked robust infrastructure experienced costly delays or material losses due to disruptions in equipment availability or logistics bottlenecks. These lessons have made long-term investment in resilient cold chain infrastructure a strategic necessity. The high cost and irreplaceable nature of biological materials make it essential to plan for every risk scenario, including equipment failure. Having backup systems in place is crucial to ensuring the continuity of operations, even in the event of unplanned temperature fluctuations.
While the challenges of storing at nontraditional temperatures are significant, they can be overcome with the right equipment, processes, and qualified personnel. Determining whether you can manage this internally requires assessing your in-house capabilities to monitor nontraditional temperatures, ensuring you have sufficient capacity for dedicated storage at these conditions, and evaluating whether your operations can withstand a 20% loss in capacity without disruption. Partnering with an experienced cold chain storage provider can alleviate this burden, ensuring that specialized storage, monitoring, and contingency planning are expertly managed while allowing you to remain focused on your core operations without the risk of capacity strain or operational disruptions.
To learn more about how to choose the right cold chain storage provider and mitigate risks for your biological samples, download our article, To build or buy? Examining the pros of building vs. buying a biorepository facility.
