The recent and ongoing development and distribution of pharmaceutical products sensitive to temperature have created more complex cold chain requirements than ever before. Numerous pharmaceutical products must remain at low temperatures, including COVID-19 vaccines, biological therapies, and cell and gene therapies. These temperatures range from standard refrigeration to specialized ultra-low temperatures requiring specific monitoring and deep cold technologies.
These products and technologies are part of an ever-growing cold chain in the pharmaceutical industry. The building of a cold chain ensures any drug or treatment with special temperature needs remains in optimal conditions from its creation to administration. Maintaining such a complex web of transport systems with exact temperature requirements is not simple, but recent advancements in this growing chain have made the process easier to manage.
Why the Pharmaceutical Cold Chain is Necessary
Until recently, for most common drugs and treatments, anything beyond refrigerated levels of as low as -10°C was unnecessary in mass quantities. However, this has changed with the recent growth of complex pharmaceuticals that are seeing more widespread use. The most well-known products in these deep cold ranges are multiple variants of the COVID-19 vaccines.
Supply chain changes implemented with the pharmaceutical cold chain need constant temperatures as low as -80°C for variants like the Pfizer-BioNTech vaccine to stay stable. The massive demand for COVID-19 vaccines and the fact that the earliest ones put to use required such low temperatures forced a rapid change in the industry.
While more COVID-19 vaccine options have entered production with less extreme temperature needs, the pharmaceutical cold chain is still necessary for many other growing treatments. Also, as more variants of the coronavirus emerge, the first vaccines and boosters that will help against these new strains will often require these same extreme temperatures.
With continuous strides in creating new COVID vaccines, it’s important to remember that they are not the only treatments that need the pharmaceutical cold chain. Even when the need for massive amounts of COVID-19 vaccines in the pharmaceutical cold chain dies down, the demand for deep cold transport and storage capabilities won’t vanish. The COVID-19 vaccines busted the door for these technologies to become more commonplace, and now that they are available, their use will likely continue.
Pharmaceutical Cold Chain Areas of Investment
The growth of the pharmaceutical cold chain contributes heavily to the sudden need for COVID-19 vaccine storage, and the progressional strides are worth going over. However, even as new treatments that require less extreme temperatures become available for COVID-19, the need for this cold chain and its advancements won’t disappear.
Several key areas in the cold chain have seen shifts and investments in technology to meet the challenges of this specialized transport network. For example, the creation of advanced containers aimed at optimizing payload volume without risking thermal performance has allowed more transportation of treatments simultaneously. Therefore, aided by newly developed insulation materials, such as phase-change materials (PCM) or vacuum-insulated panels.
These physical container advancements have allowed shifting more products through the pharmaceutical cold chain than ever before. However, they’re not the only areas that have seen improvements. The monitoring systems implemented in these cold chains are just as critical as the actual containers and have seen their share of enhancements.
Maintaining an exact temperature range is essential; data loggers and sensors receive updates to track every change that happens to treatments and drugs along the cold chain. In addition, real-time monitoring of temperature, condition, and location, along with predictive analytics and data visibility, means that mistakes in transit are unlikely to be missed.
One more major change that has helped the pharmaceutical cold chain that isn’t an advancement in technology has been the development of strong partnerships between cold chain companies. With the sudden surge in direct relief, it was important for all parts of the pharmaceutical cold chain to work together in transportation, handoffs, and storage to ensure everything moved quickly and smoothly. As a result, clear communication and seamless handoffs of products, even with constant changes in the industry.
Why Pharmaceutical Cold Chain Improvements Matter
The pharmaceutical cold chain has seen a massive influx of improvements, and it can be hard to tell what they all mean for the supply chain or why they matter. For example, more storage means shipping more pharmaceutical products simultaneously for improvements like better storage methods. However, data monitoring, close inspection, and other specialized methods are just as important as maximizing the number of pharmaceuticals shipped.
Dickson Data states, “Environmental monitoring can also be used to proactively prevent excursions.” They also note that “regular reviews of monitoring data can help to identify trends that would indicate an impending equipment failure or highlight gaps or errors in an SOP.“
Data monitoring is critical to ensure that the state of pharmaceutical products is known that using nothing that might be at risk. These data systems do wonders, but eventually, one piece of equipment could start to malfunction. Therefore, close inspection is vital to maintain alongside these newer, more advanced pieces of equipment.
Noticing trends and predicting failure can keep entire batches of deep freeze pharmaceuticals from expiring in higher temperatures. It also helps to locate gaps in the standard operating procedures that would need human intervention to fix.
It is crucial to find these problems as quickly as possible and fix them before they cause issues for product shipments. In addition, good storage practices minimize the number of pharmaceutical products at risk.
The technology and method changes in the pharmaceutical cold chain are ever-evolving. The field continues massive equipment and partnership expansion, all thanks to an influx of investment and demand that has busted the door for future innovation. There is no sign that these changes will be slowing down anytime soon, even after COVID-19 vaccines have reached a point where they demand massive quantities of transportation in the cold chain.