The Ohio headquartered company claims to be the only entity offering commercially available freezers capable of storing any COVID-19 vaccine candidate requiring ultra-low temperature (ULT) storage during last mile delivery.
Stirling has been collaborating with operations and planning committees all along the cold-chain; its goal is to maintain drug stability and maximize effectiveness upon inoculation, said the CEO, Dusty Tenney.
“We have worked with third-party logistics companies, like UPS Healthcare, to architect and build upright ULT freezer farms for vaccine distribution from region to region."
The company has increased its production by more than 40% in the last three months to meet customer commitments, he told BioPharma-Reporter.
"We experienced a large increase in demand over the past 90 days and delivered thousands of units in the prior quarter."
It is now actively scaling up material supplies and production capabilities to further increase volumes and support future demand.
“We fully understand the critical cold-chain requirements and have been proactively investing to support our customers with their ULT requirements as the vaccines are released, following clinical trial validation,” said Tenney.
Stirling has also been working with the Department of Health (DOH) for North Dakota, one of the four US states tapped to model local COVID-19 vaccine preparedness, to ensure its communities are equipped with ULT freezer capacity.
Stirling's ULT offer includes a large, upright freezer, an under-counter model and a small, portable freezer system.
The company says all of its freezers are adaptable to various power sources, and require very little power, making them all transport-ready.
"The small portable, ULT25, is probably most applicable as it is a cooler sized unit with a power adaptor that can plug directly into an vehicle power port, operate on a separate battery or potentially even a solar-panel. It can be hand carried, placed on a hand cart or set up on a counter-top to provide easy access to vaccines, while continuously providing the correct ULT temperature for long-term storage."
In their review of the market, the North Dakota authorities found that Stirling’s ULT25 was the only device that could provide cold-chain assurance, portability and temperature range required to support and maintain the efficacy of multiple vaccine candidates, said Tenney.
“The ND DOH will be using large upright freezers for their central storage banks and multiple ULT25s to deliver the vaccines from centralized warehousing to their outlying and more rural geographies and populations.”
Last mile storage
Traditional methods for ULT storage, like dry ice and liquid nitrogen, are both currently in short supply and require specialty personal protective equipment (PPE) and training for proper handling, making them an unreliable and risky source for transporting and storing a COVID-19 vaccine at the scale that is needed, said the refrigeration expert.
The World Health Organization (WHO) says that less than 10% of countries met its recommendations for effective vaccine management practices but last mile storage of the COVID-19 vaccine will be a challenge, even in wealthy countries, said the Stirling chief executive.
Developers of promising vaccine contenders such as Pfizer and Moderna report that storage temperature requirements for their products will range from -20°C to -80°C (-4°F to -112°F).
“Exposing an mRNA vaccine, like Pfizer’s COVID-19 vaccine candidate, to the wrong temperature environment could effectively kill live virus cells or harm critical proteins required for drug efficacy and effectiveness,” said Tenney.
Writing in the September edition of Nature, Florian Krammer, Professor of Vaccinology at the Department of Microbiology, the Icahn School of Medicine, in New York, notes the distribution hurdles: “In the case of mRNA vaccines, the need for frozen storage and distribution already presents challenges, especially in low-income countries in which even regular cold chains are difficult to maintain.”
Little, if any, data on shelf-life information has been published for the COVID-19 vaccine candidates, but Tenney estimates that if the vaccines have maintained their required cold-chain temperatures and have been stored properly, it is expected that their shelf life would be almost indefinite.
Biologics, cell and gene therapy support
Stirling Ultracold was founded in 2010. The CEO reports that the business has grown approximately 20% over the past four years.
Is the company doing any other work in relation to enhancing global cold-chain infrastructure to ensure safe and effective distribution of vaccines in the future?
“Even during these trying times in the pandemic, we have continued to innovate our offerings to include convenient racking and storage solutions, building management and real-time connectivity, back-up battery accessories and cart-based options to support ease of use with vaccine transport, regardless of the application.
“Furthermore, recognizing the importance of the personalized medicine in the future, our customers will also benefit post-COVID with having the necessary Stirling infrastructure in-place to support biologics and future cell and gene therapies as these future applications will also require ULT solutions for thermal protection,” said Tenney.