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With advanced therapies driving change across the pharmaceutical landscape, the EMEA region is seeing a rise in biotherapeutics development, specifically cell and gene therapies (CGTs). But as promising as these therapies are, their success depends on something deceptively simple yet logistically complex: the cold chain.
These unique challenges arise against a shifting EMEA backdrop with varied infrastructure capabilities, complex cross-border transportation and a fragmented regulatory framework that accelerates the need for specialised expertise.
“One main challenge we’re facing is the diverse regulation among countries within the EU on top of GMP Regulation,” explains Florent Belon, Managing Director at Cryoport Systems, a US-headquartered organisation offering temperature-controlled solutions to address the cold chain complexities across the EMEA region.
“There are specificities for each country. So when you add the Middle East and Africa, then you have numerous regulations that vary significantly.”
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Navigating challenges for biotherapeutics in EMEA
According to the Alliance for Regenerative Medicine (ARM), Europe hosted 19% of global gene therapy clinical trials (358), solidifying EMEA’s position as a global hub for CGT innovation. Germany, Spain, Belgium, and the UK lead due to strong regulations and infrastructure, with Germany hosting over 1,500 trials.
However, growth is expanding beyond these leaders.
“The growth is no longer confined to the ‘big five’ EU countries. We are increasingly supporting trials in Central and Eastern Europe, as well as the Middle East. This decentralisation is great for patient access but adds layers of logistical and regulatory complexity.”
Additionally, EMEA’s growing biotech infrastructure saw $6bn (€5.2bn) in venture funding in 2024. However, progress is moderated by its fragmented regulations, unlike the centralised U.S. FDA.
Country-specific rules for biologic materials, customs, and ethics create complexities. For instance, France requires National Agency for the Safety of Medicines and Health Products approvals, and Italy mandates Ministry of Health clearance. Middle Eastern countries need local approval for data logging.
“Another point is that weather conditions vary widely across the region, so solutions must be adapted accordingly. The challenges also relate to diverse regulations, such as customs clearance… adding to delays,” says Belon.
To navigate these regional hurdles, Cryoport Systems provides a complete single-vendor solution, including BioServices and biostorage, cryopreservation services, continuous cloud-based monitoring and efficient local transportation, alongside tailored consulting services to engage in early regulatory mapping. “We work with local regulatory experts to ensure our systems are compliant. For example, we pre-validate our packaging and monitoring solutions in-country to ensure a smooth passage at customs.”
Custom-built solutions from Cryoport Systems
By anticipating these regional hurdles and regulatory nuances, Cryoport Systems’ value proposition is based on delivering a customised, compliant, and seamless solution across EMEA markets.
“One of the key things is to have reliable, innovative and trustful, customised solutions which are based on underlying logistical complexity and regional climate variations,” says Belon.
Cryoport Systems also leverages cutting-edge technology to safeguard these sensitive therapies using continuous tracking, IoT sensors, and data analysers to ensure temperature compliance and detect deviations.
To enhance logistical efficiency, Cryoport Systems has built a regional network of integrated supply chain centres.
A more strategic solution is to have multiple locations, as the closer you are to patients and to hospitals, the simpler it will be logistically.
Cryoport Systems further supports clients with robust regulatory expertise. “You need to have strong and innovative trade and compliance as well as regulatory and Program Management departments,” says Belon. “They are key… in managing customs clearance… and tracking the evolution of the regulation.”
A prime example of Cryoport Systems’ collaborative approach is the co-development of its Cryoport Elite® Ultra Cold Shipping Systems alongside Sarepta Therapeutics. The result is a purpose-built solution designed for the demands of gene therapy logistics. “The Cryoport Elite® Ultra Cold system offers significantly extended hold times, an essential feature for gene therapy shipments that require ultra-low temperatures of –60 to -80°C over extended transit periods,” explains Belon.
Initially developed with Sarepta, Cryoport Systems refined the Cryoport Elite® Ultra Cold shipping system for commercial distribution. “Collaborating closely during clinical phases allowed us to refine for broader application,” says Belon. “Today, we support Sarepta’s commercial logistics, demonstrating our ability to scale solutions alongside a therapy’s lifecycle.” The advanced features include robust temperature control, continuous monitoring, and data logging that provide an unbroken chain of custody and temperature integrity, mitigating risks and safeguarding the viability of irreplaceable materials.
Integrating next-gen solutions
This innovative spirit extends beyond logistics infrastructure as the industry embraces technologies like AI, continuous monitoring, and blockchain in safeguarding and streamlining the cold chain.
Cryoport Systems is leveraging AI and analytics to transition from reactive monitoring to proactive logistics. By analysing extensive datasets, the company aims to anticipate potential supply chain disruptions, optimise transportation routes, and pre-emptively address temperature excursions. “I think the biggest challenge is to define precisely which feature we want to use AI for,” says Belon. “Because you can use AI for so many topics, so many features, so many solutions. So you need to have a very precise strategy.”
Cryoport Systems is also exploring blockchain to enhance traceability and security, valuing its potential for an immutable chain of custody record. However, as Belon notes, “the biggest challenge regarding the blockchain is the fact that all data on the blockchain is public, so there is a big challenge regarding the security and confidentiality of this data.”
Data privacy concerns, along with interoperability and scalability, remain key hurdles to widespread blockchain adoption in pharmaceutical cold chains. A 2022 GlobalData survey found only 6% of pharma executives prioritised blockchain, while 51% backed AI and 18% IoT. As Belon states, “More than a change, we see it as an opportunity, and it’s probably a race for competition.”
Sustainability as a long-term investment
Alongside technological advancements, Cryoport Systems is placing emphasis on environmental responsibility, embedding sustainability into every layer of its cold chain operations.
The commitment comes as the EU’s Corporate Sustainability Reporting Directive (CSRD) takes effect, requiring transparency around logistics emissions, packaging waste, and supply chain practices.
“The environmental impact of our activity is clearly significant and is something we’re engaged in,” says Belon, adding that sustainability is not a reaction to pressure but “part of the organisation’s DNA.”
A basis of Cryoport Systems’ strategy is reusable, low-waste packaging for longevity and performance. “If you look at what makes us known on the market today, it’s that we use reusable packaging,” Belon says. These systems, equipped with smart sensors and GPS tracking, offer a durable alternative to single-use containers.
Cryoport Systems also prioritises energy efficiency in its facilities, especially across Europe. “Our sites in France have signed contracts for renewable energy sources… we collect [waste] heat from our freezers to warm up our offices,” says Belon, referencing a heat-recapture system built with external engineers.“We’re doing it in a way to save costs, to be more efficient for the patient, for the logistics,” Belon notes. “It’s what we have to do to better serve the world.”
Investing in people, partnering for success
Cryoport Systems extends its commitment to sustainable infrastructure by prioritising its workforce and external alliances, emphasising talent cultivation and strategic partnerships to drive success.
As Belon notes, “we heard a lot about [the talent gap] in France, but… the French government has taken this topic in hand.” A key example is Cryoport Systems’ collaboration with Sanofi and Servier, co-developing the Campus Biotech Digital consortium. The groups are creating immersive virtual training modules that replicate real-world scenarios for packaging and shipping biological drugs.
“You use visors and simulate hands-on procedures … to maintain the cold chain,” explains Belon, emphasising the hands-on, VR-enabled format. These tools represent a cost-effective way to train staff without the need to take expensive lab facilities offline. Belon highlights that “we always found the appropriate people, but we are happy that we have this solution in case tomorrow we cannot.” This proactive involvement ensures a robust future workforce that understands the high-stakes nuances of biotherapeutic logistics.
Beyond training, Cryoport Systems continues to commit to fostering long-term partnerships. Along with their collaboration with Sarepta, the organisation recently announced strategic collaborations with SK pharmteco, VGXI, and Minaris Regenerative Medicine that underscore their commitment to building deep, technically integrated alliances.
Reflection and possibilities
Growing demand for cell and gene therapies across EMEA highlights the persistent cold chain complexities that include fragmented regulations, potential customs delays, and the critical need to maintain ultra-cold temperatures across borders.
Cryoport Systems meets these challenges with global expertise and strong client collaboration. “We’re not just a logistics company,” says Belon. “We’re a science-led organisation that’s deeply embedded in the therapeutic journey.”
Cryoport Systems’ risk mitigation, regulatory ties, and deep network ensure seamless delivery. Belon notes that digitalisation, automation, and AI are enabling clients to “plan for the unexpected, not just react to it.”
As regulations evolve and therapies advance, Cryoport Systems remains a trusted global partner. “The more complex the challenge,” Belon says, “the more value we can bring. That’s where we thrive.”
Learn more about globally integrated temperature-controlled supply chain support at Cryoport Systems.
Image Courtesy: Cryoport Systems
