How Many Pharma Products Are We Losing from Temperature Failures?

By Mahesh Veerina

The cold chain industry faces major risks and challenges, and these risks can have disastrous consequences. Billions of dollars’ worth of pharmaceutical products are stored and shipped at improper temperatures, or they’re delayed and end up reaching their destinations after the products have expired. These unfortunate incidents make these drugs not only ineffective, but harmful and possibly even life-threatening to the people who count on them for everything from preventing the flu to fighting cancer. Shockingly, the biopharma industry loses approximately $35 billion annually due to failures in temperature-controlled logistics.

Common Challenges Facing Cold Chain Transportation

Temperature excursions, which are defined as temperature readings that are outside recommended ranges, typically occur along planned transportation routes, which often involve multiple, complex transport methods – ranging from air transport to rail, trucking and sea transportation. It’s up to these shippers and logistics service companies to log, maintain, and report temperature, humidity and location information along the routes.

Here are just some of the common challenges of cold chain transport that companies face:

Unexpected Delays – Delays can occur along the route for many different reasons, such as traffic issues and severe weather. In these cases, transport may need to be rerouted.

Poor Documentation – Traceability in cold transport is an issue that can make or break the success of a shipment. Drivers, shippers, and logistics service companies need to be able to easily collaborate at each step along the way to make sure that documentation is detailed and accurate. Collaboration among these companies is a critical component of temperature-controlled success in the cold chain.

Changing Global Regulations – The pharma industry is significantly impacted by government regulations. There is an increased government focus on issuing policies that greatly impact the supply chain efficiency of the pharma sector in North America and Europe. Worldwide, different countries and regions often have a wide variety of local regulations regarding cold chain products.

Fluctuating Temperatures – Temperatures may fluctuate inside a trailer, damaging the pharmaceuticals. Another avenue for temperature excursions can occur when pharma products are loaded/unloaded onto transport.

Substandard Packaging – Inadequate packaging insulation often leads to temperature excursions.

The Solution: End-to-End Temperature Management and Visibility into Your Supply Chain

Temperature, humidity, light and vibration excursions can happen anywhere along the supply chain. To overcome these challenges, pharma companies would greatly benefit from end-to-end visibility in their supply chain, from the initial supplier all the way to the end patient. With end-to-end visibility, companies can capture product-level data, not just information about the truck or container the product is on, which is an incomplete picture. Having visibility into factors around condition, timing and location help create a real-time view into what’s happening at every point along the supply chain.

Fortunately, there are some innovative solutions on the market that can optimize and streamline cold chain logistics. A digital visibility platform like Cloudleaf provides complete visibility into the location of perishable products and responds in real-time by providing alerts about location and temperature excursions. Sensors can potentially be placed on every tool, part and asset within a supply chain, creating visibility and providing insights that can significantly reduce temperature excursions and other inefficiencies. Cloudleaf takes that product-level knowledge and integrates it with other contextual data, bringing formerly siloed information together for a real-time view of what’s happening on the ground as pharmaceutical goods move along their journey through the supply chain.

CSafe Global, a leader in temperature-controlled container solutions for the transport of life-saving pharmaceuticals, is partnering with Cloudleaf to deliver a custom digital visibility platform which will protect the viability of these all-too-important shipments. The platform will support both their Air Cargo track and trace technology as well as digital tracking for their Parcel and Cell & Gene packaging solutions.

Cloudleaf’s solution delivers the artificial intelligence, IoT and advanced analytics capabilities that CSafe requires, along with a highly customizable cloud-based platform. Cloudleaf’s cold chain solution combines CSafe’s state-of-the-art thermal shipping solutions with the Cloudleaf Digital Visibility Platform, providing CSafe customers and support staff with 24/7 access to monitor every shipment and intervene if necessary.

The Cloudleaf Digital Visibility Platform leverages IoT, advanced analytics, AI/ML, and sophisticated sensor technology to collect more kinds of data than has previously been accounted for, providing accurate, real-time insight into the exact time and location of temperature, humidity, or shock events all in one system, independent of the carrier.

That data is fed to the cloud and into the Cloudleaf platform, where client teams remotely track materials and goods. It creates a digital twin of a company’s supply chain, processing billions of events every second to give them diagnostic and predictive insights, giving them the information they need to resolve the root cause of the problem and serving as an all-encompassing bio-pharma temperature-controlled transport solution. 

Case Study: Global Pharmaceutical Company

Pharmaceutical companies have turned to Cloudleaf for diagnostic and predictive insights into their pharma products, including real-time location, condition, utilization and anomaly detection. A global pharmaceutical company depends on Cloudleaf for real-time visibility into critical transit information for their product including the location, arrival time and temperature excursions. The company was losing millions of dollars every year due to plasma sample spoilage, re-testing, waste and compliance issues. Cloudleaf’s solution provided end-to-end visibility and condition information of the plasma samples, from the arrival at the loading dock, to the pallets, and finally, to the freezer. Cloudleaf enabled the company to achieve 100% visibility into the flow of their plasma samples, with 100% count accuracy.

Maria Nieradka, who has over 30 years of supply chain experience in customer service, distribution, logistics, planning and manufacturing within the healthcare industry, said it best in her recent blog post: “Technologies such as the Cloudleaf platform, that enable you to get real-time, granular data providing complete visibility into your supply chain, along with smart contingency planning, are now required to deal with managing day-to-day business, achieving business strategy and being able to manage the next risk that comes your way.”

We couldn’t have said it better!