As the pharmaceutical landscape evolves, the complexity that these innovations require for their supply chains also increases. The development of increasingly specific and targeted drugs has led to more sensitive supply chains, resulting in more stringent temperature and condition monitoring.

Advanced therapies such as Debio 0228, a first-in-class theranostic pair currently under clinical development by Debiopharm International, are characterised by their sensitivity to environmental conditions. This means they require precise handling to enable control over temperature and protection from light exposure. Traditional monitoring systems, often reliant on passive data loggers that offer post-delivery insights, are increasingly inadequate.

The transition to therapies with stringent storage requirements necessitates a leap in supply chain oversight and management capabilities.

Integrating automated technologies and real-time data

To make the supply chain leap, Debiopharm recently partnered with cold chain management experts Berlinger & Co. AG. They implemented Berlinger’s revolutionary new SmartSystem, an integrated monitoring solution comprising the SmartMonitor hardware and SmartView software, into their shipments.

At the heart of the SmartSystem’s efficacy is its technical architecture, designed to meet the rigorous demands of modern pharmaceutical monitoring.  Furthermore, the system integrates location tracking through GPS capabilities and condition monitoring through light and tilt sensors. This multifaceted approach ensures the physical integrity of the shipment while guarding against tampering and mishandling, factors that can compromise the drug’s efficacy and safety.

Real-time monitoring solutions are not just beneficial but essential for maintaining the viability of extremely sensitive drugs. Berlinger’s SmartSystem provides continuous, real-time visibility into the shipment’s location, environmental conditions and overall integrity, enabling immediate intervention when necessary.

The SmartSystem’s automated technology facilitates a proactive approach to supply chain management. Automation serves two primary functions: first, it ensures the seamless upload and analysis of shipment data, significantly reducing the manual workload and potential for human error. Second, it empowers biomanufacturers with the ability to rapidly respond to potential issues. For instance, if a shipment’s temperature deviates from the required range, the system can automatically and remotely alert the manufacturer. They can then take a decision on what intervention is necessary, for example by initiating a replacement shipment.

The implementation of SmartSystem in the Debio 0228 trial provides compelling of its benefits when handling the most sensitive drugs. Throughout the trial, the system demonstrated its ability to maintain the requisite environmental conditions for the investigational drug, despite its high sensitivity and complex logistics requirements. Notably, the system facilitated real-time intervention capabilities, such as the immediate initiation of replacement shipments in response to detected anomalies, thereby mitigating the risk of trial delays and ensuring the continuity of patient treatment schedules.

Revolutionising the future of the pharmaceutical supply chain

The success of SmartSystem in the Debio 0228 trial is indicative of the broader potential for end-to-end monitoring technologies in pharmaceutical supply chain, spanning both shipping and site monitoring. Such systems offer a holistic view of the supply chain, from production through to administration, ensuring product integrity at every stage. The integration of real-time monitoring with automated technologies enables a more efficient, responsive, and secure supply chain, essential for the delivery of advanced therapies.

The adoption of these technologies also contributes to sustainability by reducing product waste, optimising resource use, and improving the overall efficiency of clinical trials. The data-driven insights provided by systems like SmartSystem can inform continuous improvement processes, leading to refined logistics strategies that further enhance supply chain resilience and reliability.

While the Debio 0228 trial highlights the challenges inherent in the modern pharmaceutical supply chain, it also illustrates how strategic partnerships and technological innovation can address these challenges. Working with a cold chain monitoring partner such as Berlinger, equipped with cutting-edge monitoring solutions, can safeguard the integrity of even the most sensitive drugs throughout their journey from clinical trials to market.

As the industry continues to advance, the role of such technologies and partnerships will become pivotal in the success of clinical trials and the broader pharmaceutical ecosystem. The implementation of end-to-end monitoring solutions represents both an operational enhancement and a strategic imperative, ensuring that the next generation of therapies can be delivered safely, efficiently, and sustainably to patients around the world.

Download the case study below to find out more about Berlinger’s solutions for real-time supply chain visibility.