What’s Slowing the Journey from Therapy to Patient? Inside the Operational Hurdles of ATMPs
As more advanced therapy medicinal products (ATMPs) move from clinical trials to commercial launch, the industry has reached a critical inflection point. The science is advancing, approvals are accelerating, but patients still face steep barriers to access.
In her Beyond Biotech podcast interview with Labiotech, Alison Pritchard, VP of Business Development for EMEA at Cryoport Systems, outlined the operational realities that stand between innovation and patient benefit. These challenges span manufacturing capacity, cold chain infrastructure, site coordination, and regional complexity.
“We’re only reaching around 20% of the eligible patient population across the U.S. and Europe,” Alison shared. “And we know that number is even smaller in other markets.”
What’s holding the market back? The issue isn’t the science, it’s the system.
A Growing Strain on Infrastructure
As the number of approved therapies increases, so does the pressure on the supporting ecosystem.
“We’re seeing a faster pace of approvals globally,” Alison explained. “But with that comes strain. On apheresis slots, manufacturing availability, access to raw materials, and even talent.”
This impacts every downstream function. Developers may have therapies ready for clinic delivery, but bottlenecks in scheduling, production, or logistics often delay delivery or limit the number of patients who can be treated at all.
“Despite manufacturing thousands of doses annually, the access gap remains massive,” she noted.
The need to rapidly build scalable operations has outpaced the availability of physical and organizational infrastructure. In many cases, even the most innovative and promising therapies cannot meet demand because the delivery systems are still catching up.
Logistical Complexity from First Kilometer to Last
With autologous therapies in particular, timing is everything. Missed pickups or delays in customs clearance can render patient-specific doses unusable.
“You’re not just managing logistics, you’re synchronizing a patient’s clinic appointment, coordinating apheresis collection, ensuring shipping to the manufacturing site, and then returning the final product in time for reinfusion,” Alison said. “Every link in that chain has to be tightly coordinated.”
That coordination gets even harder when distribution crosses international borders. Regional regulations, port clearance protocols, and varying expectations around documentation all add complexity. So does the need to maintain specific temperature conditions, whether 2-8°C, -80°C, or cryogenic levels, throughout the entire journey.
“Unless you’ve got the right expertise, systems, and partners in place, there’s a very real risk to product integrity,” she warned. “And that’s just not something you can afford to get wrong.”
Beyond Temperature Control
Cryoport Systems has long been known for its industry-leading temperature-controlled shipping systems, but Alison emphasized that supply chain excellence today is about much more than cold transportation.
“It’s not just about maintaining temperature anymore,” she said. “It’s about the Chain of Compliance®. It’s about tracking every movement in real time. It’s about having contingency plans at every step.”
That’s why Cryoport Systems’ integrated condition monitoring system not only tracks temperature, but also orientation, geolocation, shock, and humidity among other metrics. With near real-time alerts and historic audit trails, the shipping systems are designed to prevent issues before they become critical, and to provide the evidence needed for compliance.
When Contingency Planning Becomes Mission-Critical
Disruption is inevitable, but how a company responds makes all the difference. Alison shared an example of a therapeutic developer who faced a sudden site closure from their biostorage provider, which threatened the integrity and availability of critical product for ongoing clinical trials. With Cryoport Systems’ teams and processes already embedded into their supply chain strategy for logistics, they were able to move quickly.
“We executed a rapid contingency plan with no impact on clinical timelines or the patients already enrolled in the trial,” she said.
The lesson? Resilience can’t be retrofitted. It must be designed from the beginning, with the right partners, well-planned SOPs, and meaningful communication protocols.
“Even the most meticulously planned supply chain can be vulnerable to disruption,” Alison pointed out. “But you can build a team that’s agile enough to respond effectively when the unexpected does happen.”
Planning for What’s Next
For therapy developers preparing to scale, the operational and supply chain challenges of today shouldn’t be treated as temporary growing pains. They’re structural, and they demand long-term solutions.
“What we’re doing at Cryoport Systems is scaling everything we do,” Alison highlighted. “That includes infrastructure expansion, future-proofing our systems, and embedding ourselves deeper in the industry to understand what challenges our clients are facing.”
One example is Cryoport Systems’ new facility in Paris, which will act as a central European hub for logistics, GMP storage, secondary packaging, and Qualified Person (QP) release, designed to remove friction and create more reliable last-mile delivery across EMEA.
The true bottlenecks in ATMP delivery aren’t in scientific readiness, they’re in operational readiness. And they can only be solved through deep, integrated partnerships and systems that evolve with each therapy’s journey.
“We’re not just moving boxes,” Alison noted. “We’re protecting the promise of the therapy, every step of the way.”
