Operation Warp Speed, the multibillion-dollar, public-private U.S. collaboration, faces the daunting task of developing and distributing COVID-19 vaccines in a matter of months.
Following potential vaccine approval, roughly 300 million doses may be available for distribution as early as January. Additionally, other drug makers and their researchers are racing to develop their own therapies in record time.
That means major shipping and distribution firms must move quickly to create "ultra-low temperature (ULT) cold chain" plans.
The most promising vaccines in the pipeline require storage at ultra-low temperatures — as low as -80 degrees Celsius (-112 degrees Fahrenheit). That requires specialized ULT freezers in the thousands.
Logistics firms such as UPS are installing ULT freezer farms near strategic air hubs in the U.S. and Europe. The immediate goal is to store and ship a new COVID-19 vaccine when and wherever needed.
This urgent pace promises to force rapid changes in ULT freezer technology and the 3PL shipping industry. These changes are fast tracking the future of biopharmaceutical distribution and logistics.
Artificial intelligence (AI) is already accelerating drug testing, but it can also assist in the advancement of other pharmaceutical products, according to the National Institutes of Health. The ability to deliver these personalized treatments largely depends on forward-looking technology choices.
Most ULTs use commercial compressor-based technology to regulate temperatures by cycling on and off. But they are complex machines that require frequent maintenance; they need ample power and space to operate and generate excessive heat, thus ramping up HVAC costs. But they are the industry standard.
In recent years, a new ULT freezer technology has seen rapid adoption, as it overcomes many of these problems. Incorporating the basic design of the Stirling engine, these ULTs use a free-piston Stirling engine that requires few moving parts and no oil in the system.
Thus, the ULTs are virtually maintenance- and failure-free. Because the engine runs continuously, it maintains a precise steady-state temperature and recovers quickly after a freezer door opens. With this free-piston engine, it can hold more samples in a smaller footprint, use less energy and generate minimal ambient heat.
Uncertain temperature requirements of the COVID-19 vaccine candidates have also driven interest in newer ULT freezers due to their wide temperature range, capable of reliably storing samples from -80 degrees Celsius to -20 degrees Celsius.
Regardless of ULT technology, these freezers now require personnel to manually store and remove medications and samples, all while managing the performance of the freezers, usually with minimal documentation. To keep pace with industry changes, ULT freezers are turning toward solutions that allow for sample tracking, temperature monitoring and a reliable audit trail.
"Biological samples have become true company assets. As such, sample management is now even more critical."
When it comes to ULT freezers, workers require insights to avoid error or delay within their sample management processes. They open doors and sort through frost-coated samples to find the one they need, potentially letting warm air come into contact with freezer contents.
They have to be cognizant of the need to maintain the cold chain of custody as they extract samples for downstream processing, research or clinical applications. This calls for intelligence and data management via the cloud.
Biological samples have become true company assets. As such, sample management is now even more critical.
Cloud connectivity will enable sensor-based remote monitoring, control and predictive analytics across banks of ULT freezers. A continuous stream of data will detect performance characteristics to provide critical “onboard” information to ensure proper sample management, leading to increased efficacy of biologics.
Future ULT freezers will introduce guided access capabilities, which will allow the tracking and visualization of vials in laboratory management systems and at freezer access points. Researchers and 3PLs will know exactly where their samples are located inside the freezer so they can preserve the cold chain of custody, enhancing sample integrity.
Right now, workers grab boxes of vaccines and other biologics from ULT freezers and sort and pack them for shipment. Robots will simplify that process by interfacing with the ULT freezers selecting the location, placement and retrieval of doses.
Robotic precision and speed will further enhance the cold chain of custody. With the enormous growth of personalized medicine — treatments developed using gene manipulation and CRISPR technology to create targeted therapies for individual patients — ULTs will become "virtual vending machines," capable of finding one dose out of hundreds of millions for direct delivery to points of patient care.
Logistically, the software will direct the robots to move an entire freezer’s contents to other freezers, if required.
The convergence of information management, predictive analytics, robotics and AI is inevitable and will establish a more reliable, robust cold chain of custody for all types of biological materials.
As medicine and biopharmaceuticals move forward, ULT storage at facilities, including those operated by UPS, will become the clearing houses and distribution centers for novel vaccines, therapies and medical samples — stored automatically and shipped instantly on demand.
Now on the cusp of potential vaccine distribution, as well as a dramatically different future, it’s imperative we continue to adapt and grow for both.
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