Maintaining the appropriate storage temperature of biological material is critical for downstream use. However, due to the complexity of this material and its sensitivity to temperature we are seeing an increase in non-traditional storage temperature requests. In this blog we’ll explore some of the reasons why this is occurring and the associated challenges.
“Traditional” Storage Temperatures
There are many variables that can influence the temperature of biologics throughout the clinical supply chain. To meet quality standards, stability tests are conducted during collection, storage, inventorying, packaging and transportation processes. These tests ensure that the process and/or equipment used do not impose a negative impact on the material’s efficacy.
Based on these tests, the industry’s traditional temperature for biological material ultra cold storage is -80°C with a variance of -70°C to -90°C. For cryogenic material, the range is usually -150°C to -196°C. However, we are noticing an increase in requests to store material at temperatures outside of these traditional temperatures.
Increase in Storage Requests at “Non-traditional” Temperatures
As technology continuous to evolve, there is an increase in the specificity of process development and stability testing throughout drug development. Clients conduct tests to identify at which specific temperature their drug will begin to lose efficacy. For example, based on a stability test a client found that if their material gets colder than -35°C it will lose efficacy. Therefore, the material would need to be stored at -30°C (+/-5°C). This represents a challenge for industry because equipment is typically not manufactured to accommodate specific temperatures such as -30°C.
In addition to testing the impact of temperature on the material, it’s equally as important to conduct stability testing on the container in which the material is stored. For example, if the material’s temperature requirements are not compliant with the identified container, it may cause the container such as a bag or vial to become brittle, resulting in a loss of the drug.
Accommodating “Non-traditional” Temperatures
While storing at non-traditional temperatures is challenging, it is certainly achievable. With customization and some creativity, existing equipment can be modified to meet the material’s temperature requirements. Various configurations can be used to manipulate the freezer, but they do require the development of new testing protocols which increases both time and cost. Additionally, there can be an impact to capacity. By reconfiguring a freezer to meet non-traditional temperature requirements, we’ve experienced a loss of up to 20% of capacity, resulting in the need for additional equipment in order to store the volume of material.
The costly nature of this irreplaceable, biological material dictates planning for the full continuum of risk. Therefore, it’s important to have supplemental backup equipment in the rare case of a failure. This will ensure that regardless of external factors, there will not be a negative implication on the material.
Despite the challenges associated with storing material at non-traditional temperatures, it is achievable with the correct processes, equipment, and qualified personnel. To learn the right questions to ask when choosing an offsite storage provider, download your free eBook Defense in Depth: Off-Site Storage for Biological Samples and Biopharmaceuticals for Risk Mitigation.