The pandemic, which stressed all participants in the pharma cold chain, has not stopped innovation in industry practices, as exploration of the main drivers shows
Service providers and equipment vendors supporting the global pharmaceutical cold chain market in the past couple years have done double duty: not only did they have to drastically step up their supply of containers, refrigerants, and transportation services, but they also developed a raft of new configurations and service capabilities.
Those new capabilities are now providing benefits to the “rest of” the pharma cold chain—the biologic and temperature-sensitive formulations that the pharma industry is increasingly bringing to market. Cases in point:
Driving end-to-end visibility
Most sensor/datalogger vendors include some type of data collection with their devices. Elpro, a leading datalogger vendor, offers the Elpro Cloud service that not only collects in-transit condition data, but also includes data from the stationary refrigerators it monitors at labs. Packaging vendors, especially those handling pallet-scale shipments and air freight, do the same by incorporating dataloggers into their containers. And among 3PLs, it is common to provide a data collection service as part of their service-level agreements with their customers.
As alluded to, this data-gathering process is now being enhanced by third-party data aggregators, who can be hired by the pharma shipper to consolidate data from the sensors, the freight carriers, and others to present what is claimed to be a real-time, end-to-end solution. (In reality, “real time” usually involves some lag, or dropouts, such as the time in transit on an aircraft.)
“Real-time tracking enables resilience through control tower monitoring,” says Bobby Criss, digital supply chain leader, Johnson & Johnson. “The data from sensors can also be combined with other sources to understand lane trends and risks. Whether we are making decisions in real-time or using the sensors data for historical analysis, real-time tracking data provides considerable value and helps to maintain product flow to our customers.” (Criss will be expanding on this topic at the IQPC Temperature Control and Security meeting in Philadelphia, Nov. 1-3.)
ParkourSC, to cite one data-aggregation player, has added AI/ML to its offering to enable predictive analytics to the supply chain monitoring it provides. In early 2021, it announced a relationship with Cold Chain Technologies, as the latter ramped up its packaging volumes to help handle distribution of the Moderna COVID vaccine. “Beyond vaccines, the combined solution will track critical parameters for drugs and biologics, such as location, temperature, and vibration, along with data streams about weather, traffic, flight schedules, and more, to not only remove blind spots in the supply chain but flag potential issues so that they can be rectified before product is compromised,” say the companies.
Data aggregator Roambee touts the capability of its Honeycomb Visibility Platform not only for monitoring and reacting to temperature excursions for a cold chain shipment, but also to manage inventories, safety stock, and related distribution issues, such as the ability to manage inventory by the expiry dates of inventory.
The 3PLs that serve the pharma industry have their own version of data aggregation. UPS Healthcare, for example, is building out the UPS Premier service announced a couple years ago, by adding new levels of precision to its data capabilities (UPS Premier is available as silver, gold, and soon, platinum levels; the latter provides real-time tracking of shipments throughout the UPS network as well as contractors that UPS uses). DHL’s version of this aggregation is called LifeTrack; FedEx touts the combination of its SenseAware dataloggers with the Surround platform for analytics and predictive support.
Dan Gagnon, VP of global strategy at UPS Healthcare, notes that while its Premier services provide peace of mind to its pharma clients, it also has significant internal benefits for the company (which ultimately will translate into better customer service). “UPS Premier enables our operators to track packages moving through our network, when they enter one of our buildings, when they move through it, and when they leave," he says. "We might be handling thousands of packages hourly, but the operator can locate an individual package with a handheld device. The ‘secret sauce’ to our >99.9% on-time performance is that connection to operators.”
As management of the pharma cold chain tightens, other aspects of the process become better understood. An example of this is the transit from a specialty pharmacy (whose products typically involve cold chains) to the end user—the patient’s home or the hospital where a dosage might be administered.
The IT company ParcelShield, which works with many such pharmacies, says that its predictive tracking tools have prevented more than $3 billion annually in wastage in US distribution, by enabling logistics companies, or ParcelShield contractors (the company says it has 900 such contractors located all over the country) to intervene when shipments are at risk from temperature excursions or have been misrouted. The company bases its predictive ability on a database of distribution pathways, weather forecasting, and other factors; it also helps client shippers select logistics providers based on past performance. “About 90% of our business has been with pharmacies, including a just-announced relationship with Walmart,” says Sebastian Pistritto, marketing VP at the firm. “A growing part of our business is working directly with pharma companies."
Specialty pharmacies have another driver of their attention—the need to demonstrate compliance with the 4.0 version of URAC standards. URAC is a nonprofit that certifies the operational performance of pharmacies (among other tasks); many drug purchasers, such as pharmacy benefit managers, require that certification to do business with them. Specialty pharmacies have had to manage their cold chain shipments well under URAC 3.0; now under the newer standard, they need to ensure safe delivery of room-temperature (i.e., non-cold-chain) pharmaceuticals as well. Both AmerisourceBergen and Cardinal Health have set up advisory services to help their pharmacy customers meet URAC 4.0 standards.
While making a case for the lesser carbon footprint of its powered, reusable containers, Envirotainer has gathered data indicating that only 10% of the pharma industry’s overall carbon footprint is involved in logistics and distribution; the bulk is generated during raw material sourcing and manufacturing. Of that 10%, the great majority of carbon emissions would come from transportation—fuel consumption and related activity. The global logistics industry overall is trying to address those transportation deficits through actions like encouraging the production of so-called “sustainable aviation fuel,” produced from biologic sources, using electric vehicles for ground transportation, and deploying photovoltaic panels to power warehouse environmental control.
All that being said, when it comes to the pharma cold chain, the most glaring environmental problem is the accumulation of single-use, expanded polystyrene (EPS) insulation in pharma packaging. Technically, EPS is recyclable (and that is performed sometimes, in some locations), but the drive has been to develop alternative insulation materials or packaging methods—specifically reusable or recyclable containers.
The all-paper containers from Sonoco ThermoSafe or Cold Chain Technologies are gaining market share, according to conversations with those companies, even though those curbside-recyclables containers have a higher price than EPS containers. The same is true of Lifoam’s Bioffex compostable polylactic acid insulation, although pricing is influenced by the volume of packaging being ordered by clients.
On the reuse front, knowledgeable observers say that upwards of 20% of the boxes are lost after initial use; returned boxes need inspection and refurbishment, and in addition, the expense of reverse logistics needs to be accounted for. Over recent years, the concept of a reusable container has shifted from simply ordering such boxes to a “cold-chain-as-a-service” orientation. The packaging vendor works closely with the pharma shipper to devise trade lanes and return practices. In addition, boxes are being delivered prebuilt and preconditioned, relieving the shipper from those tasks. (It can take upwards of a couple days storage in a refrigerated room or chamber to precondition a cold chain box.)
Peli Biothermal was one of the originators of reusable-container services; Adam Tetz, director of global marketing, says that the company has around 70 locations worldwide where its containers are returned and readied for reuse. “Customers tell us it’s how we’re going to win their business,” he says. Most other major container providers have set up similar programs.