Baseline controlled room temperature ranges from 15°C to 25°C and is the standard defined by the United States Pharmacopeia for proper storage of pharmaceuticals and other sensitive medical products.
DHL Customer Solutions and Innovations
Key Takeaways:
· The surge in prescriptions that are going to patients’ homes and the source of where they’re coming from have changed the dynamics of cold chain shipping.
· Advanced phase change materials are being deployed in some instances as an alternative to potentially hazardous dry ice due to regulatory, health, and safety issues.
· Thermal modeling expertise provides actionable data to our customers in order to make decisions proactively, rather than reactively.
Waiting their turn for packaging and departure, some of the drug industry’s most sensitive and sophisticated products represent a diverse who’s who that are bound for the cold chain journey. Reconstituted antibiotics, insulin, messenger RNA (mRNA) vaccines, monoclonal antibodies (mAbs), cell and gene therapies (CG&Ts), and glucagon-like peptide-1 (GLP-1) agonists — each pharmacologic requires an array of storage and handling protocols that are similar and contrasting all at once. Due to a wider range of differences in chemical and biological makeup that inherently cause sensitivity to hot and cold temperatures, the stability of many drugs today can be more difficult to maintain. At the same time, demand for cold chain services continues to cause increased challenges to logistical planning and follow through.
“Some products are growing in popularity more quickly today that being able to mass produce the packaging and have it ready to go is more critical than it has been in the past, when cold chain medications were more stable in their growth,” says Scott Dyvig, vice president, business development at Altor Solutions, a packaging and insulation solution provider. “In the past, cold chain medications were more manageable for everybody to scale with it. The growth is well documented today within the shipments of biologics and some of the more temperature-sensitive products in the market and what’s being developed in clinical trial stages.”
As more cold chain-necessary drugs come to market and financial pressures related to global tariffs and the overall rising costs of healthcare persist, Altor and other companies are launching and developing new strategies to package, ship, and store items more intelligently and safely with the help of advanced technologies and sustainability solutions. “Put simply, the cold chain is no longer made up of a select few products — it is the core platform for the next generation of personalized and advanced medicines,” explains Trevor McCormick, senior manager of global packaging systems tech operations at Marken, a healthcare logistics company. “Temperature excursions can equate to product loss, and we can’t allow any infrastructure gaps whatsoever. For many patients, our shipment may be their only hope for survival, so we absolutely must get it right every time – a zero-tolerance policy for error.”
Trends Impacting Cold Chain Logistics
According to Dyvig, there are a few significant trends that he and Altor staff are especially observing as 2026 begins. “One is certainly the GLP-1 medications that are dominating the cold chain discussion,” he says. “The surge in prescriptions that are going to patients’ homes and the source of where they’re coming from have really changed some of the dynamics. Compound pharmacies haven’t had the volume that they have had recently, and I think that has elevated their cold chain packaging demand as they look for ways to distribute mass volumes of prescriptions from the relatively small footprint compared to other companies that have been doing it for decades that are built to handle that volume.”
New cold chain technologies require special consideration because temperature requirements have expanded beyond traditional ranges.DHL Customer Solutions and InnovationDirect-to-consumer delivery of today’s most delicate products, which more often include autologousCG&Ts that contain the patient’s own genetic material, is also greatly affecting the industry comprehensively, says Cael Pulitzer, managing director at Brown Gibbons Lang & Company, an organization that provides advisory financial services for companies involved in cold storage and logistics. “These types of products represent the evolution of drugs in general, which is really changing the packaging requirements associated with shipping them,” he says.
From Refrigerated to “Ultra” Cold
Once characterized by products that specifically require refrigeration while en route to their destination, the cold chain’s temperature depths have continued to evolve. “New cold chain technologies require special consideration because temperature requirements have expanded beyond traditional ranges,” says Thomas Ellmann, vice president of life sciences and healthcare specialty logistics at DHL Customer Solutions and Innovation. Baseline controlled room temperature ranges from 15°C to 25°C and is the standard defined by the United States Pharmacopeia for proper storage of pharmaceuticals and other sensitive medical products.
This is distinctly different from an environment’s ambient temperature, because active controls are required to prevent potentially dangerous temperature fluctuations that can be caused by external conditions. Standard cold chain refrigerated temperature has typically been 2°C to 8°C, with frozen products requiring -15°C to -25°C. As more innovative drugs such as mRNA vaccines, CG&Ts, and personalized medicines have entered the market, there is now the need for “deep-frozen” temperatures (-25°C -30°C), “ultra-low” temperatures (-70°C to -80°C), and cryogenic temperatures (below -150°C and reaching as low as -200°C).
The CG&Tsare arguably the most complex and temperature-sensitive therapies, according to McCormick. “And we are seeing increased volumes of these in the cold chain,” he said. “Among those, CAR-T cells require ultra-low to cryogenic. Gene therapies commonly require deep-frozen conditions, and all of these are time critical to ensure maximum efficacy for patients. There has also been a rise in mRNA vaccines, and we are going to continue to see this trend. These require ultra-low storage, although they have evolved to remain efficacious through warmer temperatures for short periods.”
The increased popularity of agonist drugs, such as GLP-1 therapies, for weight management are currently driving cold chain volume for the traditional cold segment, says McCormick. “The weight loss drug surge is creating a significant, growing volume for refrigerated shipping of 2-8° C. With the proliferation of international travel, there can be a need to maintain the coldest of temperatures for durations extending weeks.”
While refrigerated remains the vast majority of volume being distributed today, frozen is among the fastest growing segment, says Anthony Rizzo, chief commercial officer at Cold Chain Technologies. “With frozen products, historically the need was to only keep it frozen, and most companies simply put dry ice in an insulated box,” he explains. “Now many products have lower and upper limits while staying frozen due to lack of stability or primary packaging limitations. Some can't go below -80C and some can't go below -35C, but they have to be below -15C. As a result, packaging companies and logistics providers have developed specialized products and services to support these new requirements”
For many of the CG&Ts, liquid nitrogen is necessary to keep them cold enough to keep samples in the appropriate state. “Many CG&T products require to be shipped cryogenically with liquid nitrogen to maintain its integrity. This has led to meaningful growth in the demand for cryogenic shipping products and services,” says Rizzo. “While refrigerated products are much of the volume today and frozen products are one of the fastest growing segments, there are many products that can't freeze or can't get too warm."
Emerging Cold Chain Options & Best Practices
As the changes in temperature specifics have emerged and created a demand for more specialized packaging and logistical solutions, it’s almost as if the term “cold chain” is becoming somewhat antiquated. “We’ve referred to it as ‘cold chain’ distribution, but that term is really used today for anything that is temperature sensitive, whether it be too hot or too cold,” says Rizzo.
As the volume of cold chain shipments grows, the need to consider sustainability and the conservation of resources have also become priorities.AltorAt Cold Chain Technologies,advanced phase change materials (PCMs) are being deployed in some instances as an alternative to potentially hazardous dry ice due to regulatory, health, and safety issues. Among these options is EcoFlexreusable solution, a product designed to deliver temperature control for the most demanding cold chain applications. Engineered for extreme thermal performance, EcoFlex is said to have the ability to maintain various precise temperature ranges for up to seven days. A key design aspect of the EcoFlex is a universal pack-out configuration enabled by shape stable PCM refrigerants that reportedly optimize cold chain efficiency by simplifying the conditioning process, reducing pack-out complexity, and ensuring consistent thermal performance across multiple shipping scenarios.
Solutions such as EcoFlex also represent what has become an overall mindset shift in how drug companies approach packaging and logistical processes that Rizzo says he has observed during his 20 years in the industry, due primarily to regulatory hurdles. “Pharma companies are much more open to reevaluating the way they're getting existing product to market,” he says. “And that’s going through a combination of different stances, such as optimized distribution lanes and channels, utilization of new technologies, both in packaging and in freight services, and then adding more integration into their logistics models with data.”
Significant investments at DHL are currently focused on cold chain readiness, including approximately $2 billion for life sciences and healthcare infrastructure to ensure future capabilities, according to Ellmann. “This investment supports packaging initiatives within the pharma network, such as developing proprietary solutions that cover a wide range of temperature requirements from ambient to deep-frozen, while incorporating sustainability principles,” he says.
Validation protocols are also an important component of the company’s cold chain logistics, he said. “They are used consistently to maintain required temperature conditions and acceptance criteria to ensure product quality, safety, and efficacy,” Ellmann says. “They help us show objective, auditable evidence that we are following established global regulations and for showing the documented blueprint demonstrative of the mechanics of the entire cold chain from warehouse to patient.”
Reusable Resources & Sustainability
AltorAs the volume of cold chain shipments grows, the need to consider sustainability and the conservation of resources have also become priorities, says McCormick. “We need to be asking ourselves what we can do to lower costs or prevent wasting other resources, such as dry ice, to reduce our carbon footprint,” he says.
Part of this commitment at Marken is an increase in real-time monitoring temperature-controlled containers embedded with next-generation data-monitoring tools that provide enhanced thermal stability and longevity with sustainable reconditioning to power reverse logistics, reliable data acquisition, and presentation for result verification.
At Altor, sustainability efforts are best defined by a variety of expanded polystyrene (EPS) shippers, says Alex Arabea, senior brand manager, including the company’s newest innovation EmeraldPak, an EPS product made from recycled content. “This really is a new trend in the industry. Recycled content in EPS is going to be one of the big topics for the next couple years. One of the important areas that we see with EmeraldPak is that it helps bring EPS recycling to the forefront. Many people don’t think of EPS as historically recyclable, but it is. And sometimes the economics of these things are what drives the recyclability of the material,” says Arabea.
One who serves on the Pharma Committee with the International Safe Transit Association (ISTA), a unit that develops technical guidance for temperature-sensitive products, and is currently involved in authoring a white paper on sustainable packaging, Dyvig says there is growing awareness about the benefits of sustainable solutions but that there’s still room for growth. “To be able to have that recycled content feature, but in a molded, consistent product like an EPS shipper that can be validated and is very consistent in its performance will make it much more attractive to larger pharmaceutical shippers that need something that can be mass-produced,” he says. “We’ve set a goal to communicate this sustainability, how to explain the benefits, how to highlight the reasons for it, and why the product could be a good fit for customers. That's where we like to partner with our customer base — raising awareness of both the reusability of material and the actual recycling.” As part of this initiative, Altor is distributing EmeraldPak “welcome packs” across many industries to educate stakeholders.
Visions of A Smarter Cold Chain Future
The ability of the cold chain to adjust to evolving demands of the various industries it serves has been evident since its origins of railroad distribution. There’s little chance that the need to be excessively amenable is going to dwindle any time soon. “As a supply chain, the cold chain is probably the most future-ready in the world,” says Pulitzer. “It’s always been anchored in embedded technology, and within its DNA it has the most innovative packaging and technology compared to others. As drugs become more unique and more bespoke, so does the packaging. Companies are constantly trying to innovate because consumers are requiring higher functioning products.”
McCormick says it’s been determined at Marken that next-generation therapies require real-time, multi-parameter, actionable data for what is happening with product throughout transit.
“Whereas many traditional temperature logs have only provided forensic data to determine what happens after the fact, our real-time data solutions offer the ability to rapidly intervene when an adverse condition arises,” he says. “Smart tracking using Internet of Things (IoT) technology is another way we track packages faster and more reliably. We are looking for more complete, accurate data. And it needs to be at the product level, not simply outside the container. One such IoT example at Marken is a digital, serialized security seal that’s connected to real-time monitoring devices. After any seal is cut, a reported record of where and what time the seal was broken is provided to customers to confirm a digitized chain of custody. “All of this leads to an increase in logistical and operational complexity, and Marken has adapted its network to accommodate, through both human and machine resources,” says McCormick.
At Cold Chain Technologies, a suite of CCT Smart Solutions™ combines smart and connected technologies to assist customers as they navigate complexities across the logistics cycle. Cold Chain TechnologiesAt Cold Chain Technologies, a suite of CCT Smart Solutions™ that combines smart and connected technologies to assist customers as they navigate complexities across the logistics cycle is among the influences shaping the company’s future, says Rizzo. “Historically, we’ve been a thermal packaging design and manufacturing organization, but, like many other companies, we have started to develop smart packaging and making our services smarter. Some of those involve including real-time monitors, or monitoring technologies that are actually integrated into our packaging. We’re working with our suppliers, partners, and logistics providers to take data in place and show visibility. And we’re utilizing the thermal modeling expertise that we have to provide actionable data to our customers in order to make decisions proactively, rather than reactively.”
The company’s “Smart Chain Clear Gain Campaign” is also an effort to elevate digitalization in pharmaceutical logistics. “We’re utilizing our insights from the logistics channel, both from an historical and predicted area, to be smarter about the way we go to market,” Rizzo says. “It’s leveraging the right package for the right shipment. Being more proactive and understanding a risk-scoring model. There's so much great information out there, but getting it into a form that can be utilized and acted upon is where we think we have succeeded.”
McCormick envisions a future where blockchain and artificial intelligence (AI) are more significant as well. “The future-ready cold chain is digitally intelligent and predictive,” he says. “This could involve control towers enhanced with AI to predict demand fluctuations, shortages, and possible failures like flight delays, customs issues, weather, or labor shortages. This future is also potentially highlighted with end-to-end interoperability, with platforms or systems accessible by all stakeholders to facilitate seamless communication, complete data flow, and elevated transparency. Furthering these efforts will be more decentralized manufacturing, a shift from large production centers to more regional, perhaps modular, hubs. These could be complemented with adaptive regulatory bodies that design compliance processes using blockchain or AI to accelerate adoption.”
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New cold chain technologies require special consideration because temperature requirements have expanded beyond traditional ranges.DHL Customer Solutions and Innovation
