With the advent of cell and gene therapies, getting those treatments to the right patients at the right time requires both manufacturers and suppliers to offer the most reliable and timely logistics possible.
With the FDA projecting it will likely approve as many as 10 to 20 cell and gene therapies every year by 2025, the stakes are being raised to get new treatments to market. As many of those new therapies are based on an individual’s own cells, patients themselves have become a key part of the new supply chain.
In the past, a compound that had some kind of efficacy would be produced, then it would go through clinical trials for about 10 years and then be commercialized as a pill, injection or topical lotion. Today, cell and gene therapies tend to matriculate a shortened development cycle and can hit the market within five years.
In addition to advanced therapies, there is an increasing demand to transport and store specialty drugs that require timely delivery within precise temperature ranges. Keeping that temperature control requirement is integral for the patient and the product. It calls for near-perfect execution ranging from mapping out the best transportation route to how the package itself is evaluated, validated and used to maintain product integrity in all conditions.
A half century of experience
World Courier, an AmerisourceBergen company, has been in the specialty logistics business for more than half a century. The company was responsible for transporting the first clinical trial medicines related to HIV in the 1980s, and pressed airlines to allow the movement of samples to researchers working on new treatments for AIDS.
“The service is, at its simplest, the safe and controlled transport of live cells from Point A to Point B,” Simon Ellison, World Courier’s Director of Cell and Gene Therapy, said. “The challenges behind that, however, are that you’ve got to maintain the temperature, you’ve got to maintain the chain of identity, and you quite often have to ship within a very short, defined shelf life. And because it’s patient specific, you’ve got to deliver it to a named contact, whether that be a manufacturer or a clinical setting.”
Add to those challenges is moving treatments across international borders, which often involves air travel. In that case, Ellison added, security services will likely want to X-ray the package or container, which risks damaging cells or modifying them in ways that aren’t fully understood. And that is where having the right logistics plan in place that has people on the ground who speak the language and maintain approved security levels and customs clearance, is key.
“It comes down to documentation, customs knowledge and having the right credentials,” Ellison said. “In some countries they won’t allow a hand carry. In China, for example, if you are putting it on a plane or train it has to be X-rayed. The only way to maintain X-ray exemption is to do a hand carry, but if you see the size of some of the therapy carriers that’s hard to do. So, you have to have solutions to overcome those barriers and that’s where our size and experience come into play.”
The right boots on the ground
It’s those boots on the ground that make a difference. Because World Courier has its own customs brokers, paperwork issues are less of a problem, and with 140 offices in 50 countries there is always someone in place who speaks the right language and is operating in the right time zone who can jump in when there is a problem or if something gets stuck on a plane and is delayed.
The company fully embraced time and temperature monitoring that gives manufacturers the ability to track a product’s journey across the supply chain. World Courier also invests in developing new packaging solutions.
In 2016, the company debuted Cocoon, a system for large, pallet-sized shipments that are capable of maintaining temperature up to 168 hours—a full seven days—across three precise ranges that include frozen, controlled ambient and refrigerated. The system, which protects the integrity of products requiring temperatures as low as minus-25 degrees Celsius no matter how hot the outside temperature is, is also 30% lighter than most other comparable containers, thus reducing transportation costs.
The role of helping manufacturers’ transportation needs through clinical trials isn’t new for World Courier. In that arena, the company has adopted Logistics by Design framework, applied to cell and gene therapy supply chains. It emphasizes developing a target logistics profile that helps manufacturers visualize their commercial scale supply chain early on so that as the therapy works its way through the clinical trial process, they are in a good place by the time they reach the pivotal trial phase.
“In the past, manufacturers established individual supply chains for products in Phase I, Phase II, and Phase III of a clinical trial. However, when they get to commercialize and they realize the supply chain doesn’t work or it’s too expensive or too awkward to manage,” Ellison said. “What they need to do with partners like World Courier to define what their target logistics profile is, and we can use our expertise to develop the right plan that will meet their immediate needs and help them scale smoothly.”
“It’s that control and oversight throughout the supply chain that makes the difference in whether you’re successful or not.”
To learn more about how AmerisourceBergen and World Courier manage time sensitive and temperature-critical shipments focused on supporting your advanced therapy solutions visit: https://www.worldcourier.com/solutions-cell-and-gene-therapy