Joel Wayment- Vice President of Operations for 3PL Services, Cardinal Health
The arrival of fall is a favorite time of year for many of us, as trees across parts of the country burst with brilliant colors, and cool, crisp temperatures settle in. This often-calm season may seem like a particularly odd time to think about the next heat wave, but for those who work in the world of third-party logistics (3PL), the weather is always top of mind, especially those of us who are involved with biologics logistics.
As the number of biologics used to treat a variety of disease states continues to soar, we’re seeing 58% of the 50 top-selling pharmaceuticals in 2021 in the United States are now requiring cold chain handling and storage. Unfortunately, while cold chain product development soars, so do temperatures across the globe, making the delivery of these temperature-sensitive products especially daunting.
With this in mind, it is more important than ever to focus on temperature stability in the delivery of a growing number of medical products. A variation of even a few degrees during any phase of storage and delivery can diminish the effectiveness of a biological therapy, costing manufacturers and distributors millions of dollars and, ultimately, compromising clinical outcomes. It is imperative, therefore, that constant and accurate temperature monitoring become a priority, from the time biologics are manufactured to the moment they are administered to patients.
Currently, temperature failures cost the biopharma industry $35 billion a year in cold chain product losses, but new advances in shipping are poised to change that. Using cloud-based technology, some suppliers can now track the temperature, humidity and location of every dose of biologics, without using traditional packaging or even refrigerated vehicles. It is a breakthrough in 3PL that will increase logistical precision, cut down on environmental waste and deliver life-saving drugs to those who need them most, and it couldn’t come at a better time.
The Boom in Biologics
Biologics have been a part of medicine for well over a hundred years in the United States. At the turn of the last century, in fact, scientists were using therapies derived from the blood serum of horses to treat patients with diphtheria. However, after more than a dozen children died from tetanus contracted from those therapies, the government stepped in to institute a rigorous set of safety standards for biologics.
As a result, the Biologics Control Act of 1902 was established in the United States, and for the first time, the U.S. saw federal oversight of the manufacturing, testing and distribution of biologics. Over the next century the development and deployment of biologics in medicine moved slowly forward. The complexities of harvesting, preserving and delivering drugs that were derived from living organisms were challenging. Crucial advancements were made in biologics, to be sure, such as the polio and flu vaccines, and advances in blood and plasma[1]related therapies, but breakthroughs were few and far between.
Today, thanks to historic discoveries and burgeoning scientific research in fields like genomics and proteomics, biologics are quickly becoming the method of choice in the development of new medications.
The sale of cold-chain biologics is expected to reach a record of nearly $450 billion in annual sales worldwide by next year. By 2027, biologics are forecasted to overtake total sales of innovative and more traditional small-molecule drugs by more than $120 billion. The dominance of biologics in the medical field is not only continuing, it’s accelerating. As a result, delivery demands for these temperature-sensitive products are booming as well.
The Need for Constant Temperature Monitoring and Control
Because biologics are produced from living systems, they are particularly vulnerable to heat and contamination. Unlike many conventional drugs, temperature control is critical from development, to delivery, to patient administration.
For certain classes of biologics, such as novel cell and gene therapies (CGT), frozen storage of at least -40°C is necessary, and some products require cryogenic storage in temperatures as low as -180°C. These types of therapies are among the fastest-growing segment of pharmaceutical development, with the FDA expected to approve 10- 20 new CGTs per year by 2025.
The vast majority of cold chain products, however, don’t require storage at such frigid temperatures. Millions of doses of biologics and other medications like vaccines, aerosols to treat asthma, eye drops to treat glaucoma and insulin for the treatment of diabetes, must be stored in a refrigerated state, between 2° and 8° C.
While the temperatures required to preserve these products aren't quite as extreme, they can actually present a much more demanding situation.
Frozen and cryogenic cold storage guidelines allow for a variation in temperatures between 20 and 40°C. However, with refrigerated items the margin of error is much smaller.
There is only a leeway of 6° C with these items, meaning the bulk of biologic and cold chain medications need the most tightly controlled and monitored conditions.
In these products, guarding against surpassing the high and low temperature is paramount. If they get too warm, these biologics can become contaminated. Likewise, if they get too cold they can freeze, which can compromise their effectiveness.
The Heat is On
There are several factors that complicate efforts to monitor and maintain precise temperatures in cold chain logistics. First, there are many moving parts and many critical players involved.
Before temperature-sensitive biologics ever make it to the patient, they must be manufactured in precise conditions at the facility of origin. From there, they are often transferred to separate storage facilities; they are then transported to their final destinations, be it pharmacies, hospitals or doctors’ offices, via any combination of cargo planes, ships and commercial trucking operations.
It is often a daunting scenario; transferring products to many different players in different conditions and at several different touch-points requires extreme diligence and constant monitoring.
Then there’s the weather.
Any number of meteorological disruptions can threaten the cold chain delivery system. Certainly, hurricanes, wildfires, blizzards and floods pose formidable challenges, but their disruptions are often relatively short-lived.
The biggest threat is the heat.
Not only are heat waves becoming more common, they are getting longer and are affecting nearly every region of the world. This past summer, scorching temperatures shattered 7,000 records across the U.S., and for the first time ever, temperatures reached nearly 105° F in parts of the United Kingdom. Australia logged temperatures in excess of 123 ° F degrees and records were even shattered in Antarctica and the Arctic Circle.
Not only was it hotter, it lasted longer. Heat domes began to settle over dozens of states as early as May, much sooner than normal, and in China, record heat waves lingered for more than 70 days.
It is a basic rule of science that the hotter it is, the harder it is to keep something cool, and these searing summer weather patterns represent the biggest threat to cold chain logistics.
The Future of Temperature Surveillance in Cold Chain Logistics
It’s often said that necessity is the mother of invention, and despite the challenges of distributing more than a half billion vaccines worldwide, the COVID-19 pandemic forged new insights into cold chain logistics. The investments in infrastructure and technology that were made and the lessons we learned will serve us for years to come.
For decades cold chain logistics have relied on traditional shipping methods and long-established delivery routes. By using specialized, disposable packaging and by deploying bulky freezers and an ever-growing fleet of refrigerated trucks, we have managed to wedge ourselves into an existing, but often overtaxed supply chain system. It has worked, for the most part, but hasn’t always been ideal, and with the surging number of cold chain biologics in the coming years, the system will come under even more strain.
To meet these challenges, the industry is now focusing on dedicated temperature-controlled networks, instead of piggy-backing on existing methods of delivery, and is developing high-tech, reusable packaging.
It’s surprising to many people to learn that, when it comes to greenhouse gas emissions, pharma is on par with the automotive industry. The use of traditional refrigerated freight carriers is often inefficient, and one-use packaging made from things like polystyrene and cardboard, contributes tons of waste to landfills each year.
To combat both problems, Cardinal Health has collaborated with Ember Technologies to introduce the world’s first self-refrigerated, cloud-based, reusable shipping container, known as the Ember Cube.
Using a proprietary dashboard, suppliers can constantly monitor the temperature, humidity and exact location of each container in real time, and once the biologics are delivered, the container can be reused repeatedly. With the simple touch of a button, the boxes generate their own digital shipping labels and arrange for their own pick up, to go back to a storage facility to await their next delivery. The cubes are easily stackable, remarkably sturdy and will help usher in a new era in logistics.
As medicine pivots to more cold chain biological therapies, it is more important than ever to safeguard them at every step of the process - not just to protect the billions of dollars that are being spent to develop them, but to help preserve the lives of the patients who are increasingly dependent on them.
As Vice President of Operations, Joel Wayment leads Cardinal Health's 3PL business. Under his leadership, Cardinal Health 3PL (Third Party Logistics Services) has grown to become an industry leader in third-party logistics, providing warehousing, distribution, and order-to-cash services with products across a wide range of therapeutic categories including unrivaled experience bringing cell and gene therapies to market.
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