As demand for Glucagon-like peptide-1 (GLP-1) therapies grows, maintaining their integrity across the international supply chain is a complex logistical challenge. It requires meticulous cold chain management to prevent spoilage and to safeguard patient outcomes.
This article aims to focus on managing temperature excursions for a specific category of products. It expands on a previous insight article which was well received.
The Cold Chain Defined
GLP-1 medicines are pivotal in managing type 2 diabetes and, more recently, obesity. Increasing demand for these products places pressure on the international pharmaceutical supply chain. Ensuring the availability, efficacy and safety of these temperature-sensitive biological therapies relies on robust cold chain management.
Cold chain management is a meticulous logistical process designed to maintain products within a specific temperature range, typically 2°C to 8°C, from manufacture to patient.
This precision is vital for GLP-1 receptor agonists such as Novo Nordisk’s Ozempic®, Wegovy®, and Saxenda®, and Eli Lilly’s Mounjaro® and Trulicity®, which account for impressive growth in global sales volumes [1].
Navigating Transportation Challenges
Real-world challenges faced by manufacturers and suppliers are multifaceted and externalities sometimes outside of the direct control of distrubution managers.
Temperature excursions, the technical term for any deviation above or below from the prescribed temperature range, can occur during storage or transit. These include:
- extreme weather events, e.g. heatwaves;
- unforeseen delays, e.g. terrorism in transnational shipping routes;
- varied handling practices across different regions e.g. non-compliance to standards.
As is the case with vaccines, GLP-1 medicines are temperature-sensitive products that may lose potency when exposed to temperatures outside of their recommended range [2, 3].
This means that extended or repeated exposure to temperature excursions can lead to product degradation, diminishing the medicine’s therapeutic effect, reducing potency, and potentially compromising patient safety.
Financial Stakes and Impact
Whereas GLP-1 market is experiencing rapid growth driven by expanding use in obesity and weight management, making these therapies a high-value segment [4], cold chain failures are not an insignificant threat.
Spoilage and wasted product due to temperature excursions lead to substantial financial losses for manufacturers and suppliers [5].
Given the high value and sensitive nature of GPL-1 biologics, any interruption in availability or question over reliability of supply has consequences across national borders. Alongside financial losses from wasted product and recalls, manufacturers and suppliers risks severe reputational damage for their leading brands.
Advanced insulated packaging, phase change materials, and real-time monitoring systems are vital, yet complex regulatory compliance across borders adds further layers of difficulty, necessitating stringent protocols and reliable logistics partners to protect these life-changing therapies.
The future of pharmaceutical cold chain management lies not just in deploying individual technologies, but in their seamless, holistic integration across the entire supply chain. Which means connecting real-time temperature data with inventory management (ERP/WMS), quality management systems (QMS), and even predictive modelling.
Such integration would provide unparalleled end-to-end visibility, enable faster product release for all types of trials, and allow for more sophisticated, data-driven decision-making.
Ensuring Pharmaceutical Integrity and Patient Safety
The integrity of pharmaceutical products, particularly temperature-sensitive medicines, is inextricably linked to precise temperature control throughout the entire supply chain.
Deviations, whether due to heat or cold, can irrevocably compromise efficacy and safety, leading to substantial waste and patient harm.
Safeguarding pharmaceutical quality in the UK and European markets demands a holistic, multi-layered approach. This involves a synergistic combination of the following:
- robust, validated technology, e.g. advanced monitoring, validated packaging;
- rigorous operational procedures, e.g. optimised logistics and a comprehensive Corrective Action & Preventive Action (CAPA) process;
- unwavering adherence to stringent regulatory frameworks such as European Medicines Agency (EMA) Good Distribution Practice of Medicinal Products for Human Use (GDP) and national guidelines from bodies like the Medicines and Healthcare products Regulatory Agency (MHRA).
Proactive temperature management, driven by real-time data, predictive analytics, and integrated systems, is not merely a compliance requirement but a strategic imperative.
By investing in these areas and fostering a culture of continuous improvement and meticulous documentation, the pharmaceutical industry can significantly mitigate risks, reduce costly product loss, and ultimately ensure that life-saving medicines reach patients safely and effectively across the complex European landscape.
Discussion
Informed by Part 1 and this Part 2 you will, I hope, agree the distribution managers in the pharmaceutical industry, and in particular those manufacturers and suppliers of GLP-1 products, already perform an exceptionally important role. All credit to them.
That said, you will also agree that for them to continue to safeguard availability and integrity of products they are going to need help. The sort of help that reliable information technology delivers.
Once again, I invite an open a discussion with you. As we’ve seen before, sharing thoughts and opinions on these vital challenges helps us all to find improvements and solutions.
Please use the Comments section at the end of this post. Or if you prefer, please email at the usual address.
Thank you.
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References and further reading
References cited
1). Novo Nordisk (Ozempic®, Rybelsus®, Wegovy®, Saxenda®, and Victoza®) and Eli Lilly (Mounjaro®, Zepbound®, and Trulicity®) are sector-leading brand names for GLP-1 medicines.
2). https://timestrip.com/article/semaglutide-temperature-monitoring
Further Reading
URL https://www.fs2.com/managing-temperature-controlled-logistics-for-glp-1-drugs/
URL https://www.nordiccoldchain.com/from-lab-to-last-mile-cold-chain-solutions-for-glp-1-medications/
URL https://www.pharmasalmanac.com/articles/managing-temperature-controlled-logistics-for-glp-1-drugs
URL https://www.scientific-exchange.com/product-information/storage-and-stability/glp-1-ras.html
URL https://spotsee.io/blog/tempmonitor-and-glp1/
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