Increasing visibility into the supply chain with advanced tools

Once, it was standard practice for logistics managers to receive notifications of a protocol deviation when a product was in transit. And that is where the communications would end. 

Today, logistics managers need to know a lot more. The growing expectation for real-time supply chain visibility is especially critical for autologous cell therapies, in which many stakeholders need to communicate with each other to ensure that a patient’s treatment is coordinated with manufacturing and distribution. Here we describe processes and solutions that have been developed for the purpose of increasing visibility into the supply chain — including platforms and application programming interfaces (APIs), which allow disparate systems and information to be connected seamlessly and shared among stakeholders.

The value of visibility

Being able to track and monitor a therapy throughout the supply chain is vital on several different levels: Many advanced therapies, such as biologics or cell and gene therapies (CGTs), have very strict requirements for acceptable temperatures, in which any deviations may render a treatment unusable. Tracking temperature data, as well as who is handling a therapy and where it moves, is all information central to maintaining chain of custody (COC), which includes documentation that is required by the U.S. Food and Drug Administration. 

Additionally, for CGTs, chain of identity (COI) — which is a set of procedures that enable the traceability of a therapy and its components throughout the entire treatment cycle — is essential to ensure that the right therapy is received by the right patient. This is critical since the results could be fatal if a therapy is misidentified.

On top of these concerns, logistics for advanced therapies can be complicated, requiring the coordination of patients, personnel, and medical products throughout the supply chain — and often in a time-sensitive situation. Many advanced therapies and their components have a limited shelf life, particularly if they are being transported fresh rather than at cryogenic temperatures. Scheduling patients to collect therapy components or to receive a therapeutic can be challenging, particularly when their health is in flux. Further, staff must be prepared to receive and properly store sensitive products whenever they arrive at a location. With so many moving parts involved in the manufacture and distribution of advanced therapies, having visibility into where a therapy is and in what condition plays an important role in ensuring it can be effectively administered.

Using sensors for visibility

To facilitate much-needed supply chain visibility, there are a number of commonly used technologies and approaches. A primary tool is the use of internet-enabled sensors that can collect information — including temperature, location, and pressure — and can transmit this data utilizing technology such as bluetooth low energy, low-power wide area networks, near-field communication, and radio frequency identification. 

Once this information is transmitted, supply chain software allows stakeholders visibility into the status of the product. For example, Yourway offers real-time monitoring, with GPS technology embedded in its shippers, which provides information on location, exposure to light, shock, vibration, temperature and tilt, to which clients have access through a cloud-based platform.

There are some important challenges to keep in mind when utilizing sensors. There is often a tradeoff between a longer battery life, which may be needed for international transport, and a more compact unit size, which has more utility in many situations. Frequently, “real-time” monitoring truly refers to periodic rather than constant transmissions, because constant communication can quickly drain sensor batteries. Additionally, depending on the type of transmission and where a shipment is being transported, sensors may not be within communication range at all times, leading to an interruption in data.

Sharing information for visibility

A significant obstacle facing visibility throughout the supply chain is that various stakeholders — including manufacturers, health systems, and logistics providers — may use different software or other systems to log relevant data. This lack of interoperability makes it difficult for all parties to have access to all the information that they might need, and to coordinate between them. 

One approach is to utilize cell orchestration platforms, which are digital systems designed to coordinate across an advanced therapy’s entire supply chain. These help to manage tasks such as scheduling patient appointments and ensuring COI and COC across a product’s full lifecycle. Given the complexity of advanced therapy logistics, having a central tool that provides visibility into the various elements of the supply chain can help to ensure all stakeholders have the necessary information and that no details are missed. 

Similarly, APIs facilitate interoperability between stakeholders by establishing a set of protocols that enable disparate software programs to communicate with one another. This makes the sharing of important information much more straightforward. Even if different parties at different points in the supply chain use different systems to log and track relevant data, the use of an API gives each party visibility into the entire supply chain journey. 

Protecting therapies

Safeguarding important shipments and reducing risk across the supply chain depends on end-to-end visibility. Working with an experienced biopharma logistics provider, such as Yourway, is a critical element to ensure necessary monitoring and tracking throughout your product’s journey.

For more information on supply chains for CGTs, read Yourway’s whitepaper.