Mahesh Veerina, Cloudleaf

 A smooth distribution process for approved vaccines for COVID-19  will require successful product storage and packaging, seamless cold chain transit, accurate shipping, and reliable storage solutions at the point of care. A kink in the process, such as cold transport issues or logistics delays, could spell disaster for vaccine distribution.

Two main cold chain challenges need to be solved quickly to enable effective distribution of a COVID-19 vaccine.

The biologics supply chain is rife with challenges, ranging from preventing temperature excursions to achieving 100% compliance with FDA regulations. As the drive to develop more innovative drugs accelerates, the need for reliable temperature-controlled supply chains has become a critical priority. According to the IQVIA Institute for Human Data Science, the biopharma industry loses $35 billion annually as a result of temperature-control failures across supply chains. These jeopardize drug quality and stability, as well as compliance for products that are shipped globally.

2. Lack of visibility into the cold chain. 

Companies need specific information about the condition, timing, and location of products, raw materials, and product subcomponents based on real-time data. What’s the real-time location, temperature, and humidity data for perishable products? Have perishable ingredients degraded in a container stuck at a port? Did time-sensitive biomedical material end up in quarantine? How will these factors impact product delivery times? What can be done to remediate these situations? This level of oversight is crucial to improving velocity through points of congestion in the supply chain. Armed with this kind of detailed data and actionable intelligence, pharmaa companies can focus on prioritizing what is moving out, know when products move through congestion points, and leverage this data to re-route.

The foundation of supply chain agility is visibility. Visibility enables knowledge of what is going on to mobilize supply chain members and partners to act accordingly. The company that successfully discovers a COVID-19 vaccine will undoubtedly require visibility, but at this global scale and given the gravity of the situation, simply knowing where a product is will not be enough to effectively deliver it.

Supply chain sensing in a manner that is quick to detect and respond to the slight changes, signals, or influences requires a powerful sensing system. The key to this kind of sensing lies in the ability to use technologies such as Internet of Things (IoT) devices and cloud computing, while leveraging advanced technologies such as sensors, visual machine learning (ML), and integrated systems. By enabling this oversight and insight of the vulnerable points of the cold supply chain, the sensed data can be analyzed, with direct connectivity to planning and execution systems. This way, the value of timely and accurate sensing can help reduce obsolescence or allow a vaccine to be used at the most needed demand points. AI and ML are critical technologies in this process, since they can be used to analyze the tremendous amount of data that will be collected. That data can be reviewed using traditional AI/ML techniques to do predictions with a fair amount of accuracy.

For example, it is highly likely that the lead time to deliver supplies by a third-party logistics(3PL) entity to a factory can be accurately estimated, and an estimated arrival time can be provided to the “receiving” side of the factory so that the appropriate resources can be lined up “just in time.”

The World Health Organization estimates that up to 50% of vaccines are wasted globally every year due to improper temperature management and the inability of logistics to support the end-to-end cold chain. This spoilage rate could mean a billion COVID-19 vaccines could be wasted if not properly handled.

To remain viable, a vaccine needs to be maintained at 2–8 °C throughout the shipping process. It just takes one single transport leg or storage system that isn’t properly temperature-controlled to break the cold chain and spoil an entire shipment of vaccines. As the drive to develop more innovative drugs accelerates, this need for reliable temperature-controlled supply chains has become a top priority. To ensure that temperature-sensitive products don’t spoil or get damaged during transport, pharma companies need accurate, reliable tracking information.

In the past, cold chain storage providers were using a variety of siloed data sources to get supply chain information. This included everything from using manual methods such as hand-held bar code scanners to error-prone passive temperature measurements where companies don’t know when or where a temperature excursion occurred. Further, when shipments needed to be located, companies relied on email and phone calls to access needed information.

New packaging technologies and visibility software tools are emerging that can help, including the implementation of track-and-trace technology into Air Cargo container fleets. Supply chain visibility software makes comprehensive real-time tracking and intervention possible, with companies today working on individual dosage-level tracking in response to COVID-19.

One biotech organization was recently able to save $10 million to $15 million every year after deploying supply chain visibility software that enabled them to get real-time location and inventory tracking of their biomedical material containers. The company was also able to easily provide the FDA with a complete record of product movement history. Before deploying the platform, they had no method for tracking dwell time in each zone so that samples didn’t sit too long before reaching their temperature threshold.

Manufacturers also worry about product diversion and counterfeiting. COVID-19 test kits are a good example of this, since many yield inaccurate results due to tampering. Serialization has the potential to greatley reduce counterfeiting. However, serialized tracking is only available at the pallet level and during primary carrier transit. This means that there’s a potential for individual boxes to be removed from the pallet or be exposed to temperature changes and go unnoticed.

Individual dosage-level tracking would drastically increase efficiency and planning accuracy in distribution to emerging markets where delivery routes are less formal and technologically equipped, as it makes remote monitoring possible.

Mahesh Veerina is president and CEO of Cloudleaf, Inc.  

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