Courtney LeBlon, PhD, Senior Biomedical Engineer, Process Development | March 7, 2017
Cell therapies are at the forefront of saving lives – providing critical treatments to patients who might otherwise have very few viable options. Because these therapies are so unique, there are a multitude of complex challenges that must be overcome. Of particular concern is product potency. After the manufacturing process, the shipment of the final product is crucial to ensure the patient is treated with an efficacious therapy. Without a safe delivery of incoming material, the entire manufacturing process could be compromised, resulting in a lost batch or lost time, and could ultimately lead to no final product.
Choosing the right shipping container for your cell therapy materials
When selecting a shipping container to transport your cell therapy products, cost, reliability and ease-of-use should be considered.
First and foremost, the shipping container should be equipped with features that will help ensure the safety of your product. Given that most incoming products need to be shipped at a specific temperature, it’s important that a temperature tracking device is used; it’s a simple way to see if the product was maintained in an acceptable temperature range. In addition, it must be able to withstand environmental changes, orientations, throwing, banging and dropping that occur daily.
Testing is also crucial for ensuring the right container is chosen. While some cold chain logistic companies supply their own validation data, we generally recommend customers test the container with their own product in expected shipping conditions to ensure the cells are still viable and potent upon getting to their destination. In addition, customers can send the shipment to an independent testing facility, which will challenge the shipping container by running summer/winter temperature profiles.
It’s not just about the container….
While choosing the right container is important, it is also critical to select the appropriate shipping service. Smaller courier companies with specific cell therapy experience are generally preferable to large shipping companies. Given that these are critical, life-saving products, we often recommend using a specialized courier to minimize risk.
Smart shipping: the new kid on the block
More recently, there have been new, innovative shipping developments that provide users with more traceability of their cell therapy products. “Smart shippers” have GPS, as well as a variety of sensors for temperature, pressure, orientation, humidity, and light. Light sensors can indicate if the shipping container has been opened prematurely. GPS is especially useful for alerting the manufacturing facility or clinical site that the product is nearby so that preparation can begin, thus improving logistics.
While smart shippers are a great idea, for now they appear to be more suited for customers who are in Phase 3 or commercial stages—those with the higher product volumes needed to justify the cost of these shippers. The justification of using an expensive smart shipper may also depend on the product and the disease it is intended to treat, in the case of rare or difficult-to-treat ailments.
PCT has extensive experience evaluating and validating shipping containers. Often, one vital part of the shipping chain in cell therapies is cryopreservation. Click the button below to download a complementary white paper exploring the topic of cryopreservation.
Courtney LeBlon, PhD, Senior Biomedical Engineer, Process Development
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