Cold Chain Transport Blog

Cryoport is the leader in cryogenic and cold chain logistics solutions for the life sciences industry with their wide variety of Cryoport Express® dry vapor shippers, unparalleled informatics and global logistics expertise. The company has now expanded their profile with the launch of their ‘Cryoport. Certified. Cool.’ C3™ 2-8°C solution, which now gives the company complete capabilities to support the entire logistics continuum for regenerative medicine programs, specifically CAR-T therapies, and other temperature-controlled biologics or clinical materials.  

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Cryoport is the industry’s most trusted provider of cold chain logistics solutions for temperature-sensitive life sciences materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. The company stands alone and is truly unrivaled due to their continuous improvement of their products and processes by executing advantageous Quality by Design (QbD) practices in support of their logistics solutions.

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Providing $6.3 billion in funding for medical innovation to expedite the discovery, development and delivery of new treatments and cures, the 21st Century Cures Act (Cures) received overwhelming Congressional approval and was signed into law in December 2016.

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Biopharmaceuticals are inherently fragile and temperature-sensitive, requiring exacting control of shipping and storage conditions to maintain product efficacy. This is especially critical for autologous therapies, where cold chain management solutions involving suitable packaging, storage and data collection, as well as tightly controlled logistics, are needed. As companies conduct clinical trials for these innovative therapies, it is the right time to begin building a comprehensive, integrated supply chain in anticipation of product commercialization. 

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When planning your cold chain logistics strategy for temperature-sensitive biologic materials, a key consideration is minimizing risk to the quality of the commodity and its on-time delivery. Today, there are tools available that optimize outcomes by using real-world data to create better predictive models for the delivery of shipments anywhere in the world.

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Autologous cell and gene therapy processes start and end with the patient, so the transport and storage of these biologic materials pose complex logistical challenges. Depending on the severity of the patient’s illness, there may be limited opportunities for sample collection and, consequently, manufacture of the potential therapy. Furthermore, any variation in temperature or any interruption in the supply chain, can delay delivery and administration of the therapy to the patient. Irregularities in the cold chain may also affect clinical trial results by compromising data integrity as well as product efficacy and safety. To address these challenges, Cryoport and Database Integrations have launched an integrated solution to manage patient and manufacturer scheduling logistics at every stage of the supply chain for both clinical trial and commercialization processes. 

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Today, an increasing number of therapeutics and vaccines for human and animal administration require shipment in specialized shipping containers often referred to as dewars or cryoshippers. Dewars are composed of an aircraft-grade aluminum exterior that protects an inner holding chamber. The inner chamber is surrounded by a high-surface, low-density open cell plastic foam that retains -196 Celsius for up to 10 days to provide the right conditions for temperature-sensitive materials during transport. Because dewars combine advanced packaging, cryogenics and high-vacuum technology, they can be rather expensive to purchase and maintain. Since they are more expensive than a typical shipping container, such as a Styrofoam or cardboard box, dewars need to be returned for cleaning, reconditioning, testing, revalidation and reuse after each shipment. For companies with large dewar fleets, ranging from hundreds to thousands, ensuring that the dewars are returned can be an especially daunting challenge.

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Moving a laboratory can be stressful. No matter the scope of the relocation, the logistical and physical act of moving laboratories tends to be an inconvenience that disturbs the flow of information that scientists and researchers seek in their lab spaces. In addition to the hassle, the moving of temperature-sensitive materials and fragile, valuable equipment demands expert care.

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Through our strategic partnership with Worthington Industries, Cryoport will be able to augment our cold chain logistics solutions with the cryogenic transportation and storage equipment Worthington recently acquired from Taylor-Wharton. The partnership gives us an opportunity to introduce storage and fulfillment offerings to provide a wider array of services to clients.

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Moving and storing clinical trial therapeutics — such as immunotherapies or regenerative medicines — and biospecimens across the globe are especially complex operations because the materials cannot experience temperature excursions. While frozen materials are shipped and received every day, the logistics and storage of these temperature sensitive materials create new challenges for even the largest and most experienced clinical trial networks and supply chain managers.

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