Channeling cell and gene therapies through the cold chain

Jeremy Cress, Director Of Operations at Fibrocell Science looks at the transportation of cell and gene therapies, which are known for their short expiration time. Logistics professionals need to get the supply chain right every time. This presents new challenges as companies scale up from supplying small populations to supplying for hundreds and thousands of patients.

What are the main challenges that cell and gene products present for pharma supply chain professionals?

Jeremy: “The stability of the products – the shelf life – presents challenges. How do we ensure that the product doesn’t expire before it is administered to the patient?  A lot of cell and gene therapies have a very short shelf life so it’s important that the supply chain is able to support quick turnaround times.

“Ordering specialized raw materials is a challenge. You have to be on top of your game to ensure you have the proper raw materials in-house and at each of the sites. The coordination and timing of the ordering and the receipt of the raw materials presents a significant challenge as you scale up.

“Another challenge is patient scheduling. New cell and gene therapies in the rare disease space don’t have a huge patient population to treat and a lot of patients have debilitating diseases. Therefore, the logistics of moving them from their home to a specialized facility is a big challenge.”

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There is little flexibility for excursions when transporting these therapies, how does this impact the supply chain?

Jeremy: “We are in the middle of a phase one-two rare skin disease study at the moment and it is a temperature-controlled trial. The key to preventing excursions is to ensure that you run robust shipping qualification studies prior to the final product formulation. You also need to conduct multiple runs at maximum capacity and find the right shipper to transport the final product.

“The position of the temperature monitor is crucial. Therefore, finding out how long the acclimation period is in the shipper prior to the recording of data is vital. Also, sites should be trained in informing the sponsor of excursions, ensuring that the temperature monitors have the correct information and can report the high and low temperatures in-transit and the duration in which any excursions occur.

“Early phase clinical trials will allow for some tolerance, but as you get closer to commercialization, you’re going to have less ability to have those types of excursions.”

How does the way that cell and gene products are manufactured affect the supply chain?

Jeremy: “The sooner you know what [temperature] your final product is going to be stored at during shipment, the sooner you can start working on a robust logistics supply chain program and reach out to the relevant parties, not only domestically, but internationally.

“The shorter the shelf life, the less opportunity there is to ship internationally. You need to set up a third party CMO in the region to be able to process the drug – because the stability of the product is so short, it is hard to make it through customs on time.”

These therapies are becoming more commercialized. How will this affect their transportation?

Jeremy: “The transportation industry is going to have to work really closely with cell and gene therapy companies to develop a program for prioritized shipping to ensure these therapies get to the sites on time and prior to expiration. Some companies have already identified this shortcoming and have set up programs that work.

“We use a shipping program intended for  tems such as organs and heart transplant subjects. We use that shipping lane to ensure we get our products to the sites on time.

“As more cell and gene therapies are approved and they start scaling up commercially, at least a year before distribution, logistics companies will need to have a shipping program that can handle the volume needed. Otherwise, there’s going to be a huge bottleneck in that part of the supply chain and logistics process.” 

What areas of the market need to improve to assist how cell and gene therapies are transported?

Jeremy: “If the drug development companies can find a way to stabilize their products for longer periods of time, it would in turn provide the logistics companies with the time needed to deliver the product in a timely manner. At the moment, logistics companies have to come up with specialized programs for these life sciences products to ensure the therapies will get to the sites on time.”