The integrity of pharmaceutical and biological samples relies heavily on temperature stability. According to a recent cold chain logistics report, the pharmaceutical industry loses over $35 billion annually because of compromised temperature control and monitoring systems. In this article, Chase Heibel, Senior Global Product Manager at Thermo Fisher Scientific, and Alastair Carrington, CEO of Atelerix, share their insights and success stories in cold storage management.

Sample integrity is key

“Thermo Fisher Scientific's cold storage solutions are characterized by our commitment to innovation, sample security, and environmental sustainability,” Heibel explains. “We offer a broad range of cold storage lab equipment ranging from 8°C to -196°C to meet the diverse needs of scientific and industrial applications. Our equipment includes technology with connectivity enablement to help ensure the integrity and security of stored materials. Offered through Unity™ Lab Services, part of Thermo Fisher Scientific, our services include comprehensive equipment service plans, on-demand services, compliance services, preventive maintenance, and start-up/installation support.”

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Atelerix offers novel cold storage solutions by drawing its inspiration from the African four-toed pygmy hedgehog. “Crafting shelf-stable science inspired by hedgehogs, Atelerix is the answer to the cryopreservation headache,” Carrington says. “With a gel that's not just cool but doesn't need to be cold, cells, tissues, and viruses are set free from the icy grip of traditional storage and shipping methods." The company offers a range of hypothermic gel-based technologies to preserve live cells, tissues, and viruses at room temperature for up to two weeks.

Overcoming cold-storage challenges

Heibel points out the crucial role cold-storage solutions played while navigating the pandemic. “Post-COVID, the World Health Organization estimates that up to 50% of vaccines are wasted each year globally, citing temperature control as one of the primary reasons. Through the design of our products and by partnering with labs to understand their specific needs, we can address these challenges for our users. Our cold storage solutions are also designed with performance at the forefront, with specific features that support better temperature consistency and uniformity across units.”

Carrington shares Atelerix’s approach to streamlining logistics. “Our products enable our customers to simplify their shipping protocols, amplifying their sample shelf life from hours to weeks and provide flexible, low-cost supply chain and workflows from sample collection to final application.”

Impactful innovations and advancements

Consumers are interested in cold storage solutions that are consistent, reliable, scalable, and sustainable. Heibel shares how Thermo Fisher is committed to innovation and sustainability. “At Analytica 2024, we introduced our newest line of high performance ULT freezers, with enhancements to performance, user experience, and energy efficiency.” The Thermo Scientific TSX Universal Series ULT Freezers are designed to adapt to scientists’ workflows across a variety of lab settings while delivering a 33% reduction in energy consumption compared to previous generations.

ENERGY STAR® certified and produced in a zero waste to landfill certified facility, the TSX Universal Series ULT freezers are designed with sustainability in mind and provide easy-to-use information about the products' environmental impact through the ACT label program, run by the non-profit organization My Green Lab. Features like a faster door open recovery time help maintain temperature and ensure sample integrity.

Atelerix has focused on addressing the challenges around cryo-logistics and sustainability. “We're pioneering a new era of biological sample distribution removing the need for ultra-cold chain logistics, slashing shipping costs, reducing environmental impact, enabling more flexible shipping schedules, and expanding distribution territories,” Carrington explains. “Our products work with anything that has a lipid membrane. Our lineup includes: CytoStor for cells and viruses, TissueReady for tissues and organoids, WellReady for in-plate models, BeadReady for co-culture and imaging, LeukoStor for leukapheresis, and BloodReady for whole blood.”

Success stories begin with being customer-centric

“In specific circumstances, the connectivity and visibility of remote monitoring for cold storage has allowed customers to save significant costs,” Heibel says. One U.S. university faced substantial challenges in maintaining sample integrity in cold storage, risking the loss of irreplaceable research valued at more than $250,000 per unit. After suffering substantial financial losses and increased insurance deductibles due to storage failures, the university selected the Thermo Scientific™ Smart-Vue™ Pro remote monitoring solution.

“This system monitors critical parameters with redundant probes and battery backups, provides remote notifications to prevent sample loss, supports 21 CFR Part 11 compliance for full traceability, and offers comprehensive support services. The Smart-Vue Pro system improved sample protection, reduced insurance costs, and provided peace of mind for researchers and administrators, resulting in annual savings of $745,000.”

Carrington also has a success story, what he calls a “hedgehog-level win”. “A customer shipped cell lines from their U.K. labs to their sister labs in India. Normally, this process takes 2–3 days and costs at least £1,750 [$2,240] using dry ice, with a 60% cell recovery rate on good days. Using our product CytoStor for cell preservation, they shipped the cells at ambient temperature. In a twist of fate, the package was delayed in customs, with temperatures soaring between 40–50 degrees Celsius, and the total journey time stretched to 12 days. Despite this, they recovered more than enough cells to bulk up to generate stocks of cells. Traditional cryologistic methods would have left them with 0% recovery and the cost of a repeated shipment! This shipment (all in) cost ~£400 [$512], saving £1,350 [$1,730]. CytoStor protected their cells, reduced costs, and minimized environmental impact. Under normal conditions, we expect over 80% cell viability for a 12-day shipment.”

Key considerations for cold storage solutions

Although a plethora of options exist, here are a few tips to bear in mind when it comes to implementing and maintaining cold storage systems:
  • Conduct a needs assessment to ensure the cold storage solution under consideration aligns with the workflow needs.
  • Verify and validate that the cold storage units maintain a uniform temperature throughout. Fluctuations in temperature could affect sample integrity.
  • Invest in reliable backup systems such as power sources and servers. Dynamic and sensitive monitoring systems can alert users of temperature deviations or electrical malfunctions.
  • Factor in maintenance and service support to avoid operational disruptions.
  • Stress test the documentation and traceability procedures to ensure the selected device complies with the regulatory requirements. Part of this also involves training the laboratory personnel.
  • Ensure the cold storage solution is energy efficient to reduce the carbon footprint.
  • Reduce cognitive overload and opt for user-friendly interfaces. Intuitive platforms, remote access, touch screens, and mobile options are a few features worth considering.

Conclusion

Advancements in cold storage solutions impact life science research and development advancements. Organizations like Atelerix and Thermo Fisher demonstrate the importance of being customer-centric, staying informed of local and global regulatory requirements, and crafting solutions with a sustainability lens.