December 11, 2023
Ultra low temperature (ULT) storage emerges as a solid rock to safeguard the cold chain. Despite challenges, ultra-cold storage's benefits, from efficient manufacturing to prolonged shelf-life to global reach, revolutionize vaccine management.
Discover cutting-edge technologies, the role of controlled freezing, and Single Use Support's solution for vaccine manufacturing and long-term storage of vaccines.
Ultra Low Temperature (ULT) storage is a specialized form of storage that involves maintaining extremely cold temperatures, typically below -60°C (-76°F) and reaching as low as -80°C (-112°F) or even cryogenic temperatures.
This storage method is crucial for preserving the integrity and efficacy of sensitive biological materials, such as vaccines, by slowing down biological and chemical processes.
Vaccines contain components that are susceptible to degradation when exposed to higher temperatures. Exposure at higher temperatures can lead to denaturation of proteins, loss of potency, and reduced effectiveness. Ultra low temperature storage prevents such undesirable outcomes and maintains the vaccine's ability to confer immunity.
Some key components that are particularly sensitive to degradation include:
Proteins:
Many vaccines contain proteins, such as antigens or adjuvants, which are crucial for triggering an immune response. Exposure to elevated temperatures might lead to protein denaturation, rendering them ineffective.1
Nucleic Acids:
Certain vaccines, especially those based on nucleic acid platforms like mRNA vaccines, carry genetic information. High temperatures can degrade the nucleic acids, affecting the vaccine's ability to instruct cells to produce the desired immune response.2
Enzymes:
Some vaccines include enzymes that play a role in the formulation or activation of the vaccine. Exposure to higher temperatures can compromise the activity of these enzymes, impacting the vaccine's efficacy.
Preservatives and Stabilizers:
To enhance shelf life and stability, vaccines often contain preservatives and stabilizers. Examples include thimerosal, formaldehyde, and phenol. Unlike the other vaccine components, these additives do not necessarily require ultra-low-temperature storage. Elevated temperatures may still impact their effectiveness.1 2 3 4
What is essential for the ultra-cold storage of vaccines? A controlled freezing process reaching temperatures as low as -75°C (-103°F) or even cryogenic levels, along with long-term ultra-cold storage solutions such as an ultra-cold storage device. This chapter introduces best-practice solutions in controlled freezing of vaccines and ultra-low-temperature storage, as well as comparing conventional freezers with the ultra-cold storage solution provided by Single Use Support.
Read more: Advanced cold chain solutions for vaccine development
Freezing drug substances is not merely a procedural step; it's a strategic move to guarantee the stability and quality of the biologics. Beyond compliance with legal regulations for safe handling, this process allows the safe transport and storage of large vaccine volumes or their components until they are needed in the right place, mitigating the risk of structural changes and damage during transportation.
Controlled freezing of vaccines emerges as a crucial practice for ensuring both efficacy and product quality. A best practice approach involves the implementation of a plate-based freezing concept.
The choice of freeze and thaw rates becomes pivotal, with faster freezing rates demonstrating lower levels of cryoconcentration and higher protein stability—an essential factor for the efficacy of vaccines. Traditional freezers, with slow and uncontrolled freezing rates, present challenges for vaccine storage. The adoption of a plate-based controlled freeze and thaw platform addresses these challenges, ensuring homogeneity and product viability in the freezing process.
Maintaining the low temperature of frozen vaccines is crucial throughout every stage of the supply chain, including development, manufacturing, distribution, and administration at vaccination sites. The continuous cold chain relies on ultra-cold storage freezers or storage equipment, available in various sizes. Single Use Support's solution stands out as an efficient and precisely controllable option for this purpose.
Used across the biopharma industry, from laboratories to biopharmaceutical companies, RoSS.FRDG caters to various needs in cold chain storage. Its modular interior and thus its scalability, stackability, and high storage density make it a flexible solution adaptable to processes ranging from lab-scale studies to bulk production and storage of biopharmaceuticals.
The ultra low temperature storage stands out with its impressive -75°C (-103°F) temperature maintenance, creating an ideal ultra-cold environment for vaccines. The freezer's portability ensures flexibility in-plant, enabling seamless transitions between deep-freezing and subsequent processes like shipping or thawing.
Advantages over conventional solutions include reliable air temperature uniformity, exceptional storage density, cost-effectiveness, and GMP-compliant digital alarm management, ensuring the safety of stored vaccines by promptly alerting operators to temperature deviations.
The significance of temperature monitoring cannot be overstated, ensuring vaccines bask consistently within the required temperature range. Three types of monitoring are necessary to control an efficient and safe cold-chain during vaccine development.
Continuous Monitoring
Real-time vigilance characterizes continuous monitoring systems. Operators are promptly alerted to any deviations from the coveted temperature range, ensuring proactive intervention.
Data Logging
The narrative unfolds over time with data logging, where temperature data is recorded. This historical perspective allows for retrospective analysis, fostering quality assurance.
Remote Monitoring
This innovation enables the monitoring and control of storage conditions from a distance, amplifying overall system efficiency.
As we move forward, continued research and innovation in ULT storage provides the potential to tackle present obstacles like the energy usage and infrastructure needs, further enhancing the cold chain.
The ultra-cold storage solution RoSS.FRDG, offered by Single Use Support provides a practical and energy-saving option. This solution impresses with its impressive storage density, enabling more space utilization, while delivering a compact and mobile in-plant design. RoSS.FRDG is a top choice for vaccine manufacturers, distributors as well as laboratories.
With continuous improvements, ULT storage stands poised to play a central role in the evolving landscape of biologics, leading to improved worldwide health results and aiding in the battle against infectious diseases.
Head of Product Line Management
