Emerging cell and gene therapies bring unique supply chain challenges

Delivering these cutting-edge therapies requires a higher degree of integration between specialized logistics partners, patient programs and the health outcomes evidence that is required to drive physician adoption, according to Moore. The decisions a manufacturer makes during the clinical trial phase have huge implications on the commercial supply chain down the road. 

“Enabling patients’ access to these novel therapies is contingent on successfully navigating the journey from clinical development to commercialization,” Moore said. “The supply chain needs to be completely redefined as people are now part of the overall supply chain.”

Physically moving these pharmaceuticals from one place to another can be a complex process. While each individual therapy has slightly different requirements, all cell and gene therapies are composed of living cells with limited life spans, making it crucial that they are transported on time and in pristine condition. 

The storage conditions throughout the entire process are critical to ensure the drugs remain safe and viable. Any breakdown in conditions renders the entire treatment unusable, setting back manufacturers and potentially threatening patient lives.

“Regardless of the reason for a breakdown in the supply chain — whether it be in the manufacturing cycle or logistics coordination or shipping processes — they all have an extremely high cost,” Moore said. “At best, it is expensive and disruptive for the manufacturer if anything goes wrong. At worst, it could be catastrophic, with the potential to adversely impact patient outcomes.”

World Courier manages time-sensitive, temperature-critical and highly valuable shipments — including cell and gene therapies — throughout its specialized network of dedicated teams. The company’s logistics platform is used to manage critical shipments all over the world.

In order to successfully move these drugs, World Courier relies on a single quality system. This  system enables the company to deliver shipments of live cells across international and domestic boundaries while ensuring cell viability and shipment security. 

“We’re not just moving boxes for our customers. We understand that collaboration is essential for the creation of the clinical and commercial scale logistics platforms,” Moore said. “We’re ultimately able to build precisely tailored solutions for our customers.”