THE LOGISTICS BLUEPRINT: Pharma cold chain in Europe

Logistics providers today are delivering more complex and sensitive products over longer distances and, in some cases, across multiple countries. As a result, there is a heightened demand for tracking technology and cold chain packaging solutions that can protect product integrity and quality throughout deliveries. In 2020, live. Successful cold chain logistics requires highly choreographed shipping schedules, cold storage infrastructure, temperaturecontrolled packaging, tracking technology and adherence to strict regulatory guidelines.

Expanding cold chain and cryogenic storage capacity

Strategies need to be tailored to the unique product requirements. While many cold chain products require storage at refrigerated (2 to 8 °C) or frozen (-15 to -25°C), a growing number of advanced therapy medicinal products (ATMPs) require ultra-frozen (as low as -80°C) or cryogenic (as low as -196°C) storage. Cell therapies, for example, are highly labile, remaining viable only within narrow ranges of temperature and time—fresh cells have a shelf life of between 12 and 96 hours before degrading. Freezing cells below -150°C using cryogenic storage techniques can be a viable solution to enable long-term storage.

The rapidly growing pipeline of ATMPs, coupled with the increasing number of allogeneic cell therapies – often referred to as “offthe-shelf” – in clinical development, underscores the need for expanded cryogenic storage globally. By 2026, the UK, Switzerland and Germany will experience a more than 20% growth in cryogenic transportation and storage needs related to in-country clinical trials.

Robust cryogenic infrastructure in strategic locations across the world – ideally close to processing facilities and healthcare providers – is critical to enable timely and reliable access to ATMPs and to accelerate time to treatment. World Courier, for example, has doubled its cryogenic storage capacity across its global network of clinical and commercial depots since 2021 and expanded its network of liquid nitrogen (LN2) charging centres and stations to help ATMP developers build logistics platforms that support the clinical development and commercialisation of the therapies. Alloga also continues to expand its cold chain storage capacity across its network of facilities nearly 30% of the $17.5 billion spent on pharmaceutical cold chain logistics went toward packaging costs, as well as tracking technology and monitoring solutions, like data loggers.

Technological advances and innovation in design have led to the emergence of packaging solutions that offer extended temperature stability, enabling reliable deliveries over longer distances and protection against potential challenges, such as airport customs delays or extreme weather. Biopharma companies and logistics providers can deploy a wide range of temperature- controlled solutions to protect products throughout transit, such as dry shippers to support cryogenic shipments, and passive solutions, like Cocoon, that leverage various insulators and a variety of coolants. By engaging with logistics providers early in the clinical or commercialisation process, biopharma companies and their partners can identify the right packaging for their product as well as the most efficient transport route – helping them save time, reduce costs and ensure optimal security.

Real-time tracking of cold chain shipments has become increasingly important.

Technology that provides reliable, real-time monitoring data enables teams to proactively monitor shipments and identify potential risks. Logistics providers with an expansive global footprint are well-positioned to respond quickly, if needed, to take corrective measures to prevent any impact to the product. At World Courier, we are deploying a real-time location monitoring solution on all of our multi-use packages, providing our team members with enhanced visibility into the precise location of shipments in transit globally. Continued investments in tracking technology and monitoring tools are critical to increase end-to-end visibility and maintain a secure and reliable supply chain.

Maximising commercial success, patient access

The approval of the first allogeneic cell therapy offers a glimpse into what is on the horizon, particularly as biopharma companies continue to develop novel therapies to treat conditions with unmet needs. Over the last three years, the European Medicines Agency (EMA) has recommended for authorisation more than 130 new active substances, including ATMPs and orphan medicines.

As the pace of innovation continues to accelerate across healthcare, logistics providers that continue to invest in cold chain storage infrastructure, packaging solutions and advanced technology capabilities will be well-positioned to support the evolving needs of their customers and ensure their products are delivered on time and in the right condition.

The current role of the CDMO (or comanufacturer as we call it) is critical and we expect its importance to continue to grow over the coming decade. We see that there are various factors behind this trend, with different sub-sectors being affected in unique ways.

Capacity constraints and capital expenditure are overall strong driving forces, whilst in some sectors, technological advancements have increased the demand for outsourcing. Shifts in the regulatory environment have also been a material contributing factor, with new requirements demanding deeper expertise from the internal organisation. Although not new; these developments have become even more relevant over the past few years, offering an explanation as to why the overall percentage of development and manufacturing outsourced to co-manufacturers has increased.

What has then been the winning recipe for successful co-manufacturers? We believe strong regulatory and quality track records, sustained operational excellence, and leading R&D capabilities have been foundational drivers of success.