Emerging cell and gene therapies bring unique supply chain challenges

As medicine evolves, so must the logistics industry

The global medical and pharmaceutical industries are rapidly evolving, and the types of treatments available to patients are expanding on a near-daily basis. These exciting innovations tend to be fragile and often carry unique supply chain challenges, as evidenced by the rollout of the coronavirus vaccine earlier this year. 

Cell and gene therapies are some of the most promising areas of emerging medicine, offering patients relief — and sometimes even a cure — from diseases that have otherwise proven difficult or impossible to treat. Over the past five years, use cases for these therapies have expanded and significantly more companies have entered the arena. 

“In 2015, there were just over 670 companies globally in the regenerative medicine space, with financings of around $10.5 billion,” according to World Courier Regional Sales Director Keegan Moore. “By the end of 2020, we were at over 1,100 companies globally and financings are close to $20 billion. There’s been significant growth within the space, and we expect to continue to see this growth over the next five years.”

Cell therapies involve replacing, manipulating or engineering cells in our genetic material to fight diseases. Gene therapies work to correct faulty or missing genes within the patient’s DNA. These solutions are different from other pharmaceuticals in that they are highly targeted and personalized. 

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.”

Ashley Coker

Ashley is interested in everything that moves, especially trucks and planes. She covers air cargo, trucking and sponsored content. She studied journalism at Middle Tennessee State University and worked as an editor and reporter at two daily newspapers before joining FreightWaves. Ashley spends her free time at the dog park with her beagle, Ruth, or scouring the internet for last minute flight deals.