Mock shipments to mission-ready
Setting a cell therapy clinical trial up for success
A pharmaceutical company was preparing to conduct the next phase of a clinical trial for an innovative fresh CAR-T therapy for cancer patients in Japan. The logistics challenge was significant: transport patient cells 5,000 miles across the Pacific for manufacturing, then return the finished therapy within tight timeframes and without cryopreservation.
For World Courier, this meant building the operational foundation that would make tens of life-changing treatments possible over the coming year.
The situation
Fresh means fragile. Unlike traditional CAR-T therapies that rely on cryopreservation for transport, this investigational treatment required fresh handling throughout its journey.
Constraints were strict:
- 48 hours maximum to transport cells from Japanese treatment centers to a U.S. manufacturing facility
- 36 hours maximum to return the finished therapy to Japan
- 14-day vein-to-vein manufacturing timeline, meaning transport consumed a quarter of available time
- No room for delays because fresh cells cannot simply be re-frozen if something goes wrong.
"Trans-Pacific, the timelines are very challenging," explains Michael Aitken, Customer Success Project Manager, World Courier. "When you start to take up a minimum of 11 to 12 hours just for the flight, factoring in checks and security each end, that's more than half of your available transport time gone. That's traditionally why fresh wouldn't be used for lanes of this distance."
World Courier needed to prove the logistics were viable.
The solution
World Courier's strategy began with mock shipments as mission rehearsal. The team designed a three-phase testing program to validate every aspect of the transport solution.
Phase one: securing regulatory exemptions
Fresh cell therapies face security challenges. Patient material often exceeds standard liquid volume limits for carry-on items, and X-ray screening could potentially damage irreplaceable cells.
World Courier secured written exemptions from major airlines and the Transport Security Administration (TSA) in advance. This special exemption allowed shipments to bypass potentially damaging X-ray screening, and secured airline approval to carry liquid volumes exceeding standard limits in the aircraft cabin.
Phase two: feasibility testing
Before involving any clinical sites, World Courier ran three round-trip shipments between office facilities in Japan and the U.S. using saline samples. The team chose hand-carry transport with on-board couriers and a dedicated aircraft seat for the global thermal container (GTC) 4L shipping container.
These tests validated temperature control performance, airline boarding procedures, and flight routing reliability. "We had 100% success there," Aitken recalls. "The boxes were not X-rayed, the boxes weren't opened, and everything stayed in temperature as expected."
Phase three: site onboarding
With the core transport lane validated, World Courier moved to onboarding individual clinical sites in Japan. Each site performed one test shipment to confirm their packing procedures and integration with the cell orchestration platform.
The technical solution: engineering for zero deviation
For the 36-hour return leg from the U.S. to Japan, World Courier mapped out every hour of the transport window. The team identified backup airports, alternative routing options, and even emergency overland solutions like a 15-hour drive to Seattle if Californian airspace closed.
"You need to have plan A, but you also need to have plan A1, plan A2, plan B, C and so on."
System integration simplifies the complex
The sponsor onboarded an off-the-shelf cell orchestration platform for this trial based on its out-of-the-box integration capabilities. World Courier’s systems can directly communicate with this platform to create seamless information flow across all stakeholders.
When a site completes leukapheresis collection and logs the activity within the platform, it triggers a transport request to World Courier's system. When the courier scans the shipment for pickup, that milestone updates in real time for all stakeholders, eliminating manual status communications for enhanced visibility.
The outcome
By the time the first patient enrolls in the next phase of this clinical trial, World Courier will have built a comprehensive operational infrastructure. Multiple mock shipments validated the transport solution across both legs. All clinical sites received training and onboarding. Systems integration with the orchestration platform ensures seamless coordination. Robust contingency planning accounts for every potential disruption along the route.
The foundation is now in place to support tens of patient treatments expected in 2026. For each of these patients, the logistics model World Courier engineered will play a critical role in their access to potentially life-changing therapy. Beyond the immediate trial, this infrastructure represents an important milestone towards future regulatory approval and commercialization of fresh, non-cryopreserved CAR-T therapies for this customer.