Gene Therapy

The Cryoport Elite™ Ultra Cold -60 to -80°C shipping system is a revolutionary product that is purpose-built for gene therapy.

Scientifically engineered to reduce risk and surpass industry hold time standards (140+ hours), the Cryoport Elite™ Ultra Cold shipping system maintains the integrity of each payload. Combining the best features of packaging, informatics, and logistics, our Cryoport Elite™ shipping systems deliver superior performance to patients around the world.

Our focus on risk mitigation, exceptional service to streamline performance data and promote transparency for high-value commodities, and our in-depth understanding of the temperature-controlled supply chain results in a shipping system that provides maximum protection during transit of irreplaceable gene therapies and biomaterials.

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Cryoport Systems is a global supply chain leader with extensive expertise and capabilities to support the challenges of critical, high-value materials like gene therapies. Our fully-integrated supply chain platform offers comprehensive support throughout all stages and phases. With solutions that encompass BioServices and biostorage, and tailored consulting services in addition to our industry-leading shipping systems and transportation services, our support scales alongside your gene therapy development.

Our platform is specifically designed to reduce risk. We offer the gold standard in quality, products, services, processes, and technologies that drive best-practices in meeting the requirements of evolving regulatory standards.

Cryoport Systems is the expert partner for advanced therapy programs and critical biologics backed by longstanding logistics excellence and our comprehensive platform of supply chain solutions. The path from scientific discovery to an approved therapy is lengthy and intricate, requiring close oversight of the supply chain at each step. Developers of novel treatments need a strategic partner with expertise in managing the specialized demands of gene therapies to help guide their programs to success.

Our supply chain management support encompasses an entire platform of risk-mitigating solutions, making Cryoport Systems the single vendor that can support all aspects of the temperature-controlled gene therapy supply chain. Within the single vendor relationship, you are able to leverage our global network and decades of industry expertise along with our industry-leading team of experts while keeping your capital expenditures as low as possible, allowing more of your time and budget to be devoted to the life saving therapies you are pioneering every day.

At Cryoport Systems, our longstanding dedication to quality and specific focus on the life sciences industry have made us a trusted leader in comprehensive temperature-controlled supply chain solutions. We have earned our credibility by successfully supporting hundreds of clinical trials and delivering over half a million shipments of sensitive, valuable, and often irreplaceable commodities across the globe.

We drive best practices in the life sciences industry, and our experts have served as key contributors in developing ISO standards, including ISO21973, titled General Requirements for Transportation of Cells for Therapeutic Use. We work closely with ISTA, IATA, ASTM, and other internationally recognized and accredited bodies to design, develop, and execute verification and validation studies. We stand at the forefront of traceability in the biopharmaceutical supply chain, meeting GMP and GDP standards and playing a vital role in defining the compliance processes that will enable the next era of advanced medicine.

Our comprehensive supply chain platform improves and reinforces efficiencies in our clients’ systems and processes, building resilience into their strategic risk mitigation and contingency plans. Our BioServices and GMP depot equivalent Global Supply Chain Centers (GSCC) are strategically co-located to our world-renowned logistics to efficiently store, manage, and distribute critical materials with greater control. This effectively enforces risk-mitigating processes while reducing errors through a more efficient workflow, which ultimately provides optimized delivery methods to meet patient and client needs.

We support critical raw materials management and are equipped to handle cGMP starting materials and critical consumables. Our robust biopharmaceutical supply chain for temperature-controlled logistics includes the world’s largest cryogenic fleet of shippers, warehousing and fulfillment, and return logistics to overcome clients’ limited resources. We requalify every shipper, every time to ensure hold time, and use our validated Veri-Clean® cleaning procedures to avoid cross-contamination.

Cryoport Systems supports all phases of biological development from pre-clinical through to commercial. With strategic locations in the United States, Europe, and Asia, we are equipped to service global clinical and commercial programs.