Critical Crossroads for Cold Chain Storage

Sep 15, 2017
Volume 37, Issue 9

A lot of industries have temperature control requirements, but when it comes to the pharmaceutical industry, it can literally be a life or death situation. For example, when grocery products are not kept at the correct temperature, there will be spoilage and a loss of product, potentially costing hundreds of thousands of dollars. But, when it comes to pharmaceuticals, it could mean injecting life-saving vaccines that are no longer potent into patients and not knowing it until it’s too late. 

“This is the most critical level,” says Tom Grubb, manager, cold chain strategy, for American Airlines. “We are talking about the process of transporting medications and treatments in order to keep them safe and effective all the way to the patient.” 

Temperature control as it relates to pharma generally comes down to ensuring the quality, efficacy, and safety of a product being used to treat a patient—making the journey from manufacturer to endpoint absolutely critical. In the past decade or so, the pressure to keep pharma products in their correct temperature range while being transported has come under heightened scrutiny. 

Typically referred to as the cold chain, because there has been an emphasis on the cold temperatures, increasingly that temperature range is also focusing on controlled room temperature. As a result, “temperature sensitive” is being used more commonly than the phrase “cold chain.” While it may seem like a small shift in wording, it is a glaring change to those who have worked in this area of the supply chain, because it creates a new emphasis on the need for additional temperature ranges. 

According to Jim Bacon, vice president – partner client solutions for AeroSafe Global, in the early 2000s, the US and Canadian governments became more interested in the integrity of pharma products as the drugs traveled from the manufacturer to the next levels of distribution, including wholesale distributors and doctor’s offices. In recent years, he said government interest has expanded beyond just the cold temperatures. 

Bacon, a cold chain expert who frequently speaks at conferences on the subject, notes that regulations are changing. Now, when a company registers a new product, it has to talk about the storage and shipping as it relates to temperature and efficacy, making discussions about temperature sensitivity a more important part of the drug development process than it might have been previously. 

Factors driving change

The number one factor driving temperature sensitivity is technology—both inside and outside of the lab. As technology allows pharma companies to develop more  biologics, the special temperature requirements get increasingly complicated. If you factor in technology-driven trends like personalized medicine, gene editing, and immunotherapy, which all require temperature sensitivity, it’s a no-brainer that this subject area is getting more attention. 

Another contributing factor is the global marketplace. Susan Li, manager, UPS Temperature True Packaging, said that as pharma companies expand manufacturing and distribution, the temperature ranges that products are exposed to become more extreme. Take, for example, a product that is being shipped to both the Middle East and Canada. The temperature, and weather, in these locations are very different, yet the product needs to be kept in the same temperature range in both places for it to be effective once it gets to the final destination, which has also become more complicated. As Li explains, the final destination can now include a patient’s home or doctor’s office, compared to a hospital or pharmacy setting historically.

“It adds a lot of pressure to the last mile,” she says. “More products are protected, and not just those refrigerated. It has expanded into the controlled room temperature products previously shipped naked.” 

This can result in a complicated supply chain—multiple lanes, packaging needs, and temperature requirements. 

Global influence 

Global factors influencing the pharma industry’s temperature supply chain go beyond the weather conditions. Although there are global manufacturing standards, the regulations surrounding pharma products legally entering a country can vary greatly, and the results are not pretty. 

Shipments of temperature sensitive therapies can be stranded at borders while going through the proper regulatory checkpoints, with no additional ways of keeping the product in the correct range besides what it was shipped in. That makes packaging a critical component in the overall picture. 

As a result, pharma companies are increasingly looking for a variety of custom packaging solutions. From working on the front lines, Bacon has observed organizations that need multiple packaging options depending on where they are shipping to in the world. A product being shipped domestically and with a shipping time of about 48 hours may need different packaging solutions compared to if that product is being sent to Europe or Asia and may need to be kept at a certain temperature range for five or 10 days. This is the reason Bacon advises pharma companies to think about temperature sensitive requirements, including how they are going to package and ship the product as they are developing it.

 

Environmental impact 

When it comes to temperature sensitive packaging, the effects on the environment are increasingly coming up in conversations. “Everyone wants to do better for the environment,” says TJ Rizzo, senior vice president of global commercial operations at Cold Chain Technologies. “Also on everyone’s mind is cost-reduction factors.” 

This is where the reusability factor comes into play. Rizzo says technology is allowing packaging companies to come up with new materials that are not only cost-effective and reusable, but also keep the pharma treatment better protected. The reusability component is a feature the end user tends to prefer as well. 

As Rizzo notes, the end user, whether a hospital, pharmacy, or doctor’s office, has always felt a burden of what to do with the packaging once it gets there. Now, many companies offer a return shipping label that the end user can attach on the packaging and send back to the shipper. Once returned, the shipper’s experts can closely inspect the package before allowing it to go back in the system. Being able to reuse temperature sensitive packaging not only helps cut cost, but also trash. 

Getting in the game

Airlines, airports, and other transportation companies are getting wise to the fact that if they want to do business in the pharma industry, they need to pay attention to the influence of temperature sensitive drugs and therapies. 

At American Airlines, Grubb has been involved in its temperature sensitive program since the beginning and worked to build the company’s cold chain program from the ground up. The airline has not only invested significant capital into the infrastructure of its program, but also into the training of the employees who handle the pharma packages. “We make sure each person, according to their role, is trained in a certain way based upon what they do,” says Grubb.

This includes everyone from the individual loading the cargo on the plane to the sales person speaking with pharma executives about the services the airline offers. Across the board, American Airlines’ employees in this area go through reoccurring training every year to ensure they understand the importance of the procedures. 

Temperature sensitive shipping was such a vital area to the airline that in 2015, it introduced a new state-of-the-art, dedicated pharma facility in Philadelphia, PA. Focused solely on healthcare products, the  facility was designed specifically for temperature sensitive shipments, and features among other things: A deep frozen area for shipments between -10°C and -20°C; a zoned active container management area with powered charging stations for up to 30 electronically controlled units; advanced technology for 24/7 monitoring of products, including proactive alarming, validated to 0.25°C; and full backup power generators in the event of a power failure. 

Future outlook 

As technology changes, more biologics come to market, and medicines become more personalized, the temperature of therapies when stored and transported is going to become even more important—and complicated. Experts are optimistic about the future of temperature sensitive solutions. 

Stephen Laaper, principal of strategy and operations for life sciences and healthcare at Deloitte, says the increasing ability to detect and sense temperatures across the entire supply chain, from the manufacturing, through shipping, and all the way to the final destination, will continue to be critical—and getting those results in real-time will drive innovation.

Being able to collect real-time data about a product’s temperature, or other excursion that could adversely impact the treatment, will make a considerable difference in the way companies can respond to these situations in the future. And while the technology might be there, it  really comes down to cost. 

Laaper points out that, fortunately, the cost of such technology is starting to drop, and temperature sensors that can perform this type of reporting and monitoring are being come accessible. 

 

Michelle Maskaly is Pharm Exec’s Senior Editor. She can be reached at [email protected] and on Twitter at @mmaskaly

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