Life Sciences Industry Needs Better Cold Chain Management
A Pharmaceutical Commerce article

Making the loss of refrigerated biological materials a "Never Event".

Last month, a federal jury in California decided a verdict that will give any pharma company, biobank, lab or fertility clinic that operates below-zero refrigeration systems a cause for concern: The jury awarded nearly $15 million to five litigants whose cells (eggs or embryos) were lost when a cryogenic storage tank deployed at a fertility clinic failed in 2018.1 And the settlement might be just the first as plaintiffs apply for class-action status for other recent refrigeration failures.

Notwithstanding the human suffering in these incidents, they should be virtually nonexistent—a type of “never event,” to borrow a term from the healthcare field where medication errors can lead to loss of life. So says Rick Kriss, CEO of KLATU Networks, a company that has devoted most of the past decade to developing preventive-maintenance systems tailored to low-temperature refrigeration. “In my opinion, failures of this kind involving priceless biological materials and decades of research should also be ‘never events.’”

Kriss has been on a years-long campaign to get modern, internet-networked monitoring systems installed throughout the life sciences ecosystem, from manufacturers of refrigeration equipment to labs, biobanks, hospitals and fertility clinics. Cryogenic storage is widely used to preserve biological materials. There are biobanks that have materials safely stored for decades, and these materials are helping researchers develop new drugs or therapies every day.

The advent of biotechnology—using living cells to produce medically important compounds—has greatly expanded the need for these high-tech refrigeration systems; now they are a component of many pharma production processes.

Cryo tanks and alarm bells

Most cold-storage systems have a monitoring system that sounds an alarm but only after the system has failed and the onset of biodegradation or complete loss has occurred, says Kriss. But when an alarm occurs, a near-immediate response is required to move products to standby freezers. Off-hours failures can be overlooked or responded to only slowly. “Traditional monitoring systems have blind spots,” he says.

The KLATU technology, branded as TRAXX and covered by multiple international patents, comprises Wi-Fi-connected sensors on various mechanical components of a refrigeration system, as well as for environmental conditions. With a stored history of literally millions of data points, across a wide variety of commercial systems, Traxx, according to Kriss, can anticipate deteriorating operations and provide a signal for initiating maintenance procedures. Sophisticated analytics processes run nightly to compare real-time operations with design performance, and then call out trouble spots. Because Wi-Fi sensor devices are complex and networks are not always reliable, Traxx also uses proprietary analytics to score and monitor Wi-Fi link quality for every asset as well.

Broadly, a closer monitoring of refrigeration system performance should allow for significant savings in power consumption—an important consideration for many research laboratories, which can consume 10x more power per square meter compared to commercial office space.2 “When you can show that some freezers waste 30% to 50% of energy consumed, you get peoples’ attention,” says Kriss.

Payback—usually three years or less—comes from reduced repair costs and the energy savings which results from the repairs, reduced HVAC loading and longer asset life. Avoiding catastrophic failure, of course, translates into an immediate payback.

The TRAXX system has been deployed at 8 of the top 10 and 15 of the top 25 largest pharma companies in the US, according to Kriss.

1. “$15M awarded over eggs, embryos ruined at fertility clinic.”

2. Laboratories for the 21st Century: An Introduction to low–energy design. U.S. EPA and U.S. Department of Energy Office of Federal Energy Management Programs.

Article originally posted in Pharmaceutical Commerce.

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