Cold Chain Monitoring: Ensuring Drug Safety in Pharma Supply Chains

The global transportation of time and temperature-sensitive cargo in the pharmaceutical industry necessitates a robust cold chain. This critical supply chain ensures the safe delivery of life-saving medications that impact the lives of millions.

Historically, pharmaceutical products did not rely on temperature-controlled environments during transportation. However, as the industry has evolved, the emergence of biologics and their effectiveness in fighting diseases has prompted the need for cold chain logistics. Moreover, modern medical advancements and treatments demand precise temperature and time control, amplifying the significance of a reliable cold chain.

Problems with the Complexity of the Healthcare System

The production, transportation, and storage, incur significant costs. Any disruption or dysfunction within the process can result in the loss of effectiveness for an entire batch of biologics, leading to product wastage and substantial financial losses for stakeholders. Moreover, wasted products can result in the loss of valuable data gathered during clinical trials. Beyond financial implications, the ineffectiveness of these vital medications denies the public access to vaccines that could safeguard them against diseases.

Inadequate logistics can have severe consequences for an organization, including the potential for lawsuits stemming from subpar treatment outcomes. Investigating such cases can be a labor-intensive process, often requiring up to 40 hours of work and costing hundreds of thousands of dollars.

The Importance of Cold Chain Monitoring:

The cold chain refers to the temperature-controlled supply chain that ensures the integrity of temperature-sensitive products, such as vaccines, biologics, and other pharmaceuticals. Maintaining the appropriate temperature range during transportation, storage, and distribution is critical to preserving the potency and effectiveness of these medications. Failure to adhere to temperature requirements can result in the degradation of drugs, rendering them ineffective and potentially harmful to patients.

The Cold Chain and the Pharma Industry

Ensuring proper temperature monitoring and management at every stage of the process is essential in the implementation of cold chain logistics. Temperature excursions pose a critical challenge for pharmaceutical companies as the efficacy of their products heavily relies on maintaining the appropriate temperature conditions. Effective monitoring during distribution is crucial to preserving the potency and quality of pharmaceuticals.

The demand for temperature-sensitive products has surged due to the advancements in therapies derived from human cells. As a result, the need for efficient cold chain logistics has grown significantly.

The cold chain industry has made remarkable progress by developing cutting-edge equipment, including innovative temperature sensors and data loggers. These advancements have paved the way for integrated track and trace systems and real-time remote temperature monitoring. The integration of these technologies proves immensely beneficial in ensuring the safe and reliable delivery of sensitive products.

Cold Chain Solutions for Pharma

• Temperature-controlled packaging solutions

In response to the rising demand for cold chain solutions, pharmaceutical companies have placed significant emphasis on investing in the necessary infrastructure and services to facilitate these specialized therapies. The global expenditure on biopharma cold chain logistics has exhibited a consistent upward trend since 2018 and is projected to experience further growth of 25 percent in the coming three years, reaching a substantial value of $21.3 billion by 2024.?

Notably, in 2020 alone, approximately $5 billion, which accounts for nearly 30 percent of the total $17.5 billion spent on pharmaceutical cold chain operations, was allocated to expenses associated with packaging, as well as tracking technology and monitoring solutions such as data loggers. [Reference]

• Cryogenic storage and transport

While a significant portion of cold chain products necessitate refrigerated storage at temperatures ranging from 2 to 8°C or frozen storage at temperatures between -15 and -25°C, an increasing number of advanced specialty therapies, such as cell and gene therapies, require an even more stringent environment. These therapies mandate ultra-frozen storage conditions, reaching temperatures as low as -80°C, or even cryogenic storage at temperatures as low as -196°C.?

Furthermore, these specialized products possess an exceptionally short shelf life, intensifying the intricacy of the supply chain. Flawless execution becomes imperative throughout the entire distribution process, encompassing transportation from the manufacturer's facility to a third-party logistics (3PL) storage facility, and subsequently, deliveries to each point of care. The demanding ultra-frozen or cryogenic requirements, coupled with the time-sensitive nature of these therapies, magnify the complexity involved in ensuring a seamless supply chain operation.

• Monitoring and tracking technology

To ensure compliance with the strict temperature and time constraints associated with cutting-edge specialty pharmaceuticals, it is imperative to implement tracking technology, specifically smart-monitoring solutions, that offer comprehensive visibility throughout the entire supply chain. These advanced technology solutions and smart-monitoring tools accurately monitor and transmit essential metrics, including ambient temperature, internal temperature, light exposure, tilt, pressure, physical shock, and geographic location.?

Leveraging the latest advancements in Global Positioning System (GPS), Global System for Mobile Communication (GSM), and Bluetooth Low Energy (BLE) technologies, the tracking capabilities enable the precise collection of data, which is then securely transmitted to a cloud-based platform. This ensures that stakeholders can access the metrics whenever and wherever needed, facilitating effective monitoring and prompt decision-making throughout the supply chain journey.

Planning for the Future

The healthcare and pharmaceutical industries are experiencing a relentless pace of innovation, with manufacturers consistently introducing groundbreaking specialty products that provide substantial advantages to patients worldwide. Among these new therapies, an increasing number will have specific cold chain storage requirements.

In fact, according to recent reports, the growth of cold chain products is projected to outpace that of non-cold chain products by approximately twofold within a six-year timeframe spanning from 2018 to 2024. This emphasizes the growing significance of cold chain logistics in facilitating the safe and effective delivery of these innovative treatments.

In order to enhance the worldwide availability of innovative specialty therapies, pharmaceutical companies must establish early collaboration with their logistics partners during the planning phase. This collaborative approach enables the development of a comprehensive end-to-end logistics strategy, ensuring timely and optimal delivery of the products while maintaining their desired condition.

By investing in advancements in cold chain packaging solutions, storage infrastructure (especially in key global markets), and tracking technology, both pharmaceutical companies and logistics providers can equip themselves to facilitate the secure and dependable distribution of these specialized products on a global scale. Such investments play a crucial role in expanding access to these therapies and ensuring their safe and efficient delivery to patients worldwide.