When the COVID-19 pandemic was moved into the mainstream of global society, the research and scale-up of mRNA vaccines illustrated an impressive response based on an existing infrastructure throughout the life science community. Directing this response were major international health organizations marshaling the resources of a robust pharmaceutical industry already at work on a new generation of vaccines.
Vaccine storage has always been a matter of temperature uniformity and stability in commercial refrigeration systems. As new mRNA vaccines requiring non-traditional low temperatures for vaccines were placed onto the market at the height of the pandemic, the demand for ultra-low temperature (ULT) freezers set off a struggle between supply and demand that continues somewhat to this day. In the ultra-low freezer industry, it was chaos.
According to Piper Mullins, President of the International Society of Biological and Environmental Repositories (ISBER), the pandemic triggered a strong and immediate reaction from the industry’s primary collective organization.
“We know that the development of new mRNA vaccines and the need for wide distribution put enormous pressure on the ultra-low freezer and biorepository industry,” said Mullins. “It introduced ultra-low freezer technology to many who may not have considered this need before. Many cold chain issues occur in the ‘last mile’ of vaccine distribution, with samples lost due to improperly handled freezers.”
“ISBER offered our shared expertise in cold chain management to educate new users of ultra-low temperature freezers as part of COVID-19 vaccine distribution programs via our position statement for management and use of ultra-low temperature freezers.”
Mullins emphasized that these guidelines, which remain in force today, draw on accepted practices that ensure robust ULT product storage and distribution routinely used by biorepositories and represents a consensus view from the biobanking community.
The long-term implications on the ultra-low freezer market are emerging. Trends in the ultra-low freezer industry are measured in terms of unit sales, product type and orientation (upright vs. chest), operating temperature range and price. It is clear that the demand for ultra-low freezers hit the industry with a blow that stressed resources in raw materials, manufacturing throughput, labor, logistics, transportation and last-mile delivery to facilities unfamiliar with the nuances of ultra-low storage. There are, however, no reliable estimates for the worldwide demand for ultra-low freezers. Most companies prefer to keep their projections under wraps.
Johannes Brok, President and Member of the Board, PHCNA (formerly Panasonic Healthcare Corporation, formerly SANYO Biomedical), offered a first-hand account of what it was like on the supply side in North America and beyond.
“The pandemic set the ultra-low freezer industry into a mild panic as demand exploded,” said Brok. “Many customers had no idea what a -80°C freezer was in the first place. Moderna and Pfizer were pushing us. Logistic companies were ordering 500 to 1000 ultra-low freezers at a time, all to be delivered ASAP. There was also confusion about storage temperatures, so we had to educate new customers.”
“Factories were ramping up to three shifts working 24/7. In our case, vacations in our primary manufacturing facility were deferred to meet global demand,” said Brok of the immediate adjustment his team in North America made to manage the situation. “Turnaround times for containers were within 4 hours, and we needed to deliver freezers in the strangest places to customers who had never needed an ultra-low freezer before.”
Ultra-low refrigeration illustrated in context with other scientific refrigeration. Ultra-low freezers require special refrigeration platforms apart from conventional refrigeration widely available in the marketplace. Colder than standard freezers and refrigerators and warmer than cryogenic and liquid nitrogen freezers, ultra-low freezers provide long-term storage for a wide range of uses. While conventional ultra-low freezers demand as much power as a common American household, new ENERGY STAR certified freezers have extended storage temperature capability while reducing energy costs.
Brok said that despite the chaos “there was vibrant energy in our company because we were directly helping through the pandemic. We fielded weekly calls from CNN, ABC, FOX and other media. We saw famous scientists standing in front of our ultra-low freezers, lab freezers and medical refrigerators, all talking about COVID. At the same time, however, we were worried about our families, our health, employees, travel restrictions and the possibility of COVID cases in the factory and offices. Concurrent with this, we had to respond to a shortage of semiconductors used in our control systems.”
Brok acknowledges that the pandemic put his industry on the front lines of clinical response unlike anything before.
“We helped keep the healthcare system running. From major pharmaceutical companies to last-mile delivery providers in clinics and drug stores, we educated the market. Internally, we created better ways to manage large projects. Today, it feels like the biotechnology and biopharma industry are operating at a higher level, capable of battling another pandemic in a shorter time as new mRNA-based vaccines are introduced and as new therapies spin-off in an upside to this unfortunate situation,” said Brok.
“Today, we’ve adapted to a higher cold chain product sales volume. We work with our factory to manage demand as we see an uptick in an already active pharmaceutical industry. And as laboratories started to re-open, we started to see a demand for CO2 incubators and other products essential to basic research and production.”
As for the future, Brok is realistic: “The long-term need for ultra-low freezers will sustain itself, especially as storage demand increases and facilities work to replace less efficient freezers with new, more energy-efficient models.”
Perhaps the best information on demand trends comes directly from field sales representatives who use a consultative sales approach rather than order-taking via online sites or through conventional distributors. These independent representatives are experts on the demand side of the ultra-low freezer equation. They often sell competing ultra-low freezer brands and, as a result, select from within their product offerings to provide the best fit for customers.
According to independent sales representative Kevin Theis, DAI Scientific Equipment, Mundelein (Chicago), IL, an avalanche of a new type of customer required more education.
“We were seeing markets we didn’t see before, including public health at the most local level. These sales discussions were about supply and demand and not so much about the cooling technology involved. The most recent advances in ultra-low refrigeration related to meeting ENERGY STAR® criteria for better energy efficiency; suddenly, operating costs were less of a concern than availability. With vaccine shipments coming on so quickly, previous investments in technology came into play. Pharmaceutical companies were saving more specimens, and long-term storage capacity became a concern,” said Theis.
On the West Coast, Brent Kolhede, Laboratory Equipment Company, Hayward, CA, was grateful for the opportunity to step into the forefront of the COVID experience.
“We had the privilege of serving those on the front lines of every phase of the battle. We supplied 4°C, -20°C and -80°C cold storage first to those testing for COVID, then to other clients working on COVID vaccines, and finally, thankfully, -20°C and -80°C storage freezers to those administering the vaccines, all while navigating the most challenging supply chain issues of my career. Many people unfamiliar with ultra-cold storage tried to prepare for receipt of the vaccines, yet they did not always know what they needed.”
While the market evolves as pharmaceutical manufacturers seek to develop vaccines that may not require extreme storage temperatures, the need for long-term ultra-low storage of clinical samples from extraordinarily large populations will certainly expand. Scientific research, reaching into the past from millions of frozen stored samples, and connecting these original specimens to current conditions, has always provided another data point that can help triangulate investigations into chronic illnesses. Thus, the need for ultra-low freezers will remain. But the vaccine market has expanded the envelope as far as required temperature storage points.
While the COVID-19 pandemic created an unprecedented demand for ultra-low freezers and other medical refrigeration, it appears that much of the acute need has been satisfied. But, the curve has shifted. The same mRNA techniques that accelerated the development of COVID-19 vaccines promise new research investments into molecular biology and associated disciplines that may yield better treatments for a range of disorders such as Parkinson’s, MS, ALS and others. More clinical specimens will require even more biorepository space for long-term storage. Coincident with this demand, too, facility managers will replace older freezers with ENERGY STAR® Certified products developed to reduce operating costs and lower the carbon footprint in compliance with corporate mandates and environmental policies.
About the Author: Bill White is CEO of Offenberger & White, Inc. (OffWhite) and a member of Labcompare's Editorial Advisory Board. White co-founded OffWhite, a Marietta-based marketing consulting firm, in February 1985. Before co-founding OffWhite Marketing, White was a co-founder and director of marketing for Queue Systems Inc. He also previously served as the director of marketing for Forma Scientific, Inc. (now Thermo Fisher) from 1976 to 1980, after spending several years as chief technical researcher and writer in the Forma R&D and engineering group. Throughout his career, White has provided extensive technical assistance in the design, development, application and marketing of numerous applied technologies employed by the biomedical, life science and industrial laboratory community.