Cold Chain Planning: A Must for Regenerative Medicine Companies

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By Staff Reports

(DGIwire) – Regenerative medicines—including cellular therapies and tissue-engineered products—can be life-changing and lifesaving for patients. But as Applied Clinical Trialsreported in August 2016, these new technologies bring challenges as well. Consider, for example, “autologous” therapy, in which a patient’s own cells are extracted, modified and reinfused. The manufacture of this type of therapy requires obtaining cell materials from the patient, sending them to processing and manufacturing facilities, and then shipping the product back to the same clinical site, leaving no room for errors in packing, shipping, tracking or traceability.

In addition, notes Applied Clinical Trials, biopharmaceuticals are incredibly sensitive to the slightest changes in temperature, pressure, humidity or other conditions. Finally, biologic-based products and therapies are not like traditional medicinal pills that have months of shelf life at room temperature. Cell and tissue-based medicines have, at most, a few days of shelf life in which to be administered to the patient, requiring vigilance in the distribution chain to meet this requirement. For regenerative medicines, a very specialized approach that involves both cold storage temperature control and scheduling is absolutely vital to maintain the integrity of the product.

Agencies such as the International Society for Biological and Environmental Repositories (ISBER), the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA) either have issued or are reviewing guidelines for the storage and distribution of biological materials. These guidelines focus extensively on quality systems, including documentation of compliance with current Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).

“Effective cold-chain transport and logistics requires an understanding of the performance of various shipping technologies, and an appreciation of continuous monitoring, recording and documentation of the condition of the biologic material and its packaging throughout the journey,” says Mike Rice, President and CEO of BioLife Solutions, a Seattle-area company supplying biopreservation tools to the cell therapy industry.

BioLife Solutions, with its joint venture partner SAVSU Technologies, has developed a cloud-based cold chain logistics system branded as biologistex™. The heart of this system is the evo™ Smart Shipper, a leading edge, durable and reusable “smart box.” The biologistex SaaS application receives live data streams transmitted from the evo while in transit. Critical payload information—such as location, payload temperature, pressure, humidity and tilt—is provided to users through this cloud application. Users can set up email and text alerts to be sent to destination contacts informing them that the evo is approaching the destination, when it arrives, when it is opened and how much shelf life remains, to ensure time-sensitive, life-saving cellular therapies are administered to the patient within a validated stability profile.

“Even if a clinical study is still in the protocol-planning stage, it is not too early to incorporate effective cold chain logistics into the planning process. This can ensure the greatest possibility for success, since cells will arrive alive and viable and able to provide a therapeutic effect,” adds Rice.

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