Cold chain challenges evolving with industry, Cryoport

By Melissa Fassbender

- Last updated on GMT

(Image: iStock/Milous)
(Image: iStock/Milous)
While the temperature is dropping outside, keeping clinical trial therapeutics and biospecimens at the right temperature during transportation is a challenge year-round.

To learn more about the cryogenic storage and transportation of clinical trial samples, vaccines, stem cells, and other biologic sensitive materials, talked with Mark W. Sawicki, Ph.D., CCO at Cryoport about the evolving challenges facing the industry as these materials, and their shipment processes, become increasingly complex. What are the challenges of storage and transportation?

Mark W. Sawicki:​ For clinical trials or commercial distribution, materials must be maintained within a very narrow range of temperatures. To ensure the safety and efficacy of the product, the chain of condition and chain of custody need to be tracked for the life of the commodity during shipment and storage.

In addition, simple changes to a cryogenic shipper during transport, such as the orientation of the package, can have an adverse impact on the hold time of that shipper. All these elements need to be monitored for commodities as sensitive as what is being transported cryogenically.

Clients want access to this information 24/7, and, as a result, all storage and transportation solutions must be integrated with state-of-the-art technology to ensure conditions and location are tracked and recorded from end to end and that this information is always available to clients. 

There are also specific challenges related to shipping and customs regulations for transporting biologic materials internationally, the complexities of certain shipping lanes, and the management of large dewar fleets used to transport the materials including reverse logistics and cleaning and decontamination of the reusable shippers that are moving sterile product. Plus, we are always working against the clock.

Like the manufacturing process, the supply chain — both shipment and storage — needs to be a robust, validated processes and include 21 CFR Part 11 and cGMP compliant storage, controlled access to the materials and 24/7 environmental controls.

Biostorage units must include redundant freezers, backup power and 24/7 alarms and alerts. Planned maintenance and calibration schedules must be tightly adhered to for all equipment, and all inventory and condition data must be audit-ready. With new materials how have these challenges evolved?

Sawicki: ​As mentioned above, the new autologous therapies have very complex supply chains that include the hospital, manufacturing and storage locations, and the point of care.

Throughout the process, temperature and location data must be tracked, recorded and reported, and risk mitigated: a simple deviation can destroy the commodity being shipped or stored.

The sheer number of cryogenic shippers that must be purchased, qualified, validated, returned and maintained for any commercial launch is also a significant challenge in order to support hundreds of thousands of individualized patient samples moving around the world at any given time. As clinical trials move to more remote areas what new challenges arise? How are companies overcoming these issues?

Sawicki: ​Shipping, biostorage and fulfillment capabilities are playing an increasingly more important role in maintaining product quality while accommodating shipping timelines and workflow management for sponsors, investigators and researchers.

As clinical trials move to remote areas, time and infrastructure can be even more challenging. It is why we encourage sponsors to consider developing their supply chain plan concurrent with developing the protocol, since product quality is so heavily reliant on absolute control over temperature and condition. 

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