menu toggle

When the cold chain gets tested:

How planning and partnership prevent risk in CGT logistics

In cell and gene therapy (CGT) logistics, there is no such thing as a routine shipment. Every movement is a high-stakes hand-off where timing, temperature and traceability must all hold steady. And sometimes, despite diligent planning, the unexpected still happens.

The scenario: a customs delay at –150 °C

A cryogenic dry shipper containing a patient’s autologous cells was en route from a European collection site to a U.S. manufacturing facility.

The route was fully validated — but at the final transit point, customs authorities requested additional documentation before release. With the shipper sealed at ≤ –150 °C, every hour mattered.

“In CGT, you can’t improvise when a shipment is already on the move,” explains Kelly Frend, Senior Manager, Personalized Supply Chain. “You have to know exactly what you’ll do if a delay occurs — long before it happens.”

The GDP-trained and pre-approved local World Courier team escalated through the 24/7 operations center.

How World Courier responded

The GDP-trained and pre-approved local World Courier team escalated through the 24/7 operations center.

Within minutes, continuous temperature monitoring flagged that the shipment hadn’t cleared as planned. The local World Courier team — already GDP-trained and pre-approved as part of the controlled network — escalated through the 24/7 operations center.

A replacement LN₂ shipper was prepared nearby and customer service colleagues coordinated directly with customs to expedite clearance.

Because the lane and contingency plan were validated in advance, the swap could be authorized and completed before any risk to the therapy.

“Our technology shows when a shipment is trending outside normal parameters,” says Eric Schier, Senior Manager, Personalized Supply Chain. “That early visibility gives us time to act fast and keep conditions completely stable.”

The GDP-trained and pre-approved local World Courier team escalated through the 24/7 operations center.

Why it worked

This wasn’t luck, it was vigorous preparation. The route had been assessed, the partner trained, and the escalation process rehearsed.

World Courier’s monitoring, data, and decision-making framework ensured a seamless recovery — long before the delay could impact the therapy.

“Every shipment has a plan B,” says Kelly. “We map the risks, validate the lane and brief everyone involved — from the driver to the client — so if something changes, everyone knows exactly what to do.”

Group of World Courier associates having a business meeting

Lessons for CGT sponsors

  • Validate every lane. Confirm — through data and testing — that every route can consistently meet time and temperature requirements before the first live shipment.
  • Design contingency early. A plan only works if it’s built into the process.
  • Invest in real-time visibility. Data is the trigger for intervention.
  • Choose a partner, not a provider. Shared responsibility creates faster decisions.

The outcome

The patient’s therapy arrived on time, within range, and fully documented — zero deviation, complete traceability.

For Kelly and Eric, it is another example of how proactive planning and partnership prevent risk long before it reaches the cold chain. Their focus is always on the patient.

“Success isn’t measured in percentages,” says Eric. “It’s measured in patient outcomes.”