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Gene Therapy - Cryoport Systems

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class="screen-reader-text">Search for:</span> <input type="text" class="search-field" placeholder="Search" value="" name="s" title="Search" /> </label> <input type="submit" class="search-submit" value="Search" /> </div> </form> </div> </div> </nav> </div> <a class="cta" href="https://www.cryoport.com/contact/request-a-quote/" target="_self">Request a Quote</a> </div> </div> </header> <div class="submenu"> <div class="container"> <a class="btn default" href="https://www.cryoport.com/request-info/" target="">Request Info</a> <a class="btn default quote" href="https://www.cryoport.com/contact/request-a-quote/" target="_self">Request a Quote</a> </div> </div> <main id="content" class="site-content" role="main"> <article> <div class="page-content"> <div class="hero_media hide_none overlay-enabled short " style="background-image:url('https://www.cryoport.com/wp-content/uploads/2023/11/Gene-Therapy-Header.jpg')"> <div class="container"> <h1>Gene Therapy</h1> </div> </div> <div class="breadcrumb_wrap"> <div class="container"> <span><span><a href="https://www.cryoport.com/">Home</a></span> &gt; <span><a href="https://www.cryoport.com/applications/">Service Areas</a></span> &gt; <span class="breadcrumb_last" aria-current="page">Gene Therapy</span></span> </div> </div> <section class="column-content image-content standard list-style-1 top margin-no-top reversed hide_none"> <div class="container"> <div class="image-content__image"> <img src="https://www.cryoport.com/wp-content/uploads/2024/04/Gene-Therapy-Body-4_blue-gloves.jpg" alt="Cryoport Elite Ultra Cold Shipper testing" /> </div> <div class="image-content__content"> <h2>Comprehensive solutions for gene therapy distribution</h2> <h4>Our comprehensive supply chain platform encompasses a full range of risk-mitigating solutions</h4> <p>Distribution of gene therapies requires ultimate care, as these life-saving treatments are irreplaceable. At Cryoport Systems, your gene therapy products are in the safest hands. Our purpose-built and temperature-controlled solutions are backed by a decades-long track record of success in logistics excellence and a comprehensive platform of supply chain solutions.</p> <p>With tailored assistance throughout the entire supply chain, our fully integrated platform manages the complexities of the gene therapy industry with specialized services around BioServices and biostorage, customized consulting, and more.</p> <p><a class="btn default" href="https://www.cryoport.com/enabling-the-outcome-gene-therapy/" rel="noopener">LEARN MORE ABOUT HOW CRYOPORT SYSTEMS IS ENABLING THE OUTCOME™</a></p> <p>&nbsp;</p> </div> </div> </section> <section class="section accordion_wrap margin-no-top hide_none"> <div class="container accordion_container"> <div class="accordion_intro"> <h2>Devote more of your time and resources to your life-saving work</h2> <h4>Cryoport Systems can manage the complexities of the gene therapy supply chain</h4> <p>With our full-scale platform of solutions, gene therapy developers can devote more of their time and resources to their life-saving work while our team manages the unique complexities required for all aspects of the temperature-controlled supply chain. Our industry-leading supply chain platform encompasses a full range of risk-mitigating solutions that integrate seamlessly with our expert logistics services for comprehensive support.</p> </div> <div class="accordion full-width accordion_al_left"> <h3>Revolutionary Dry Ice Shipping System</h3> <div> <p>The <a href="https://www.cryoport.com/solutions/shipping-systems/cryoport-elite/elite-ultra-cold/">Cryoport Elite® Ultra Cold</a> -60 to -80°C shipping system is a revolutionary product that is purpose-built for gene therapy.</p> <p>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.</p> <p>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.</p> <p><a class="btn default" href="https://www.cryoport.com/solutions/shipping-systems/cryoport-elite/elite-ultra-cold/" rel="noopener">Learn More</a></p> </div> <h3>Fully-Integrated Supply Chain Platform</h3> <div> <p>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 <a href="https://www.cryoport.com/solutions/bioservices/">BioServices and biostorage</a>, and tailored <a href="https://www.cryoport.com/solutions/consulting-services/">consulting services</a> in addition to our industry-leading <a href="https://www.cryoport.com/solutions/shipping-systems/">shipping systems</a> and <a href="https://www.cryoport.com/solutions/transportation/">transportation</a> services, our support scales alongside your gene therapy development.</p> <p>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.</p> </div> <h3>Strategic Partner of Choice</h3> <div> <p>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.</p> <p>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.</p> </div> <h3>Focus on Quality</h3> <div> <p>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.</p> <p>We drive best practices in the life sciences industry, and our experts have served as key contributors in developing ISO standards, including ISO21973, titled <em>General Requirements for Transportation of Cells for Therapeutic Use</em>. 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.</p> </div> <h3>Scalability and Reproducibility</h3> <div> <p>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.</p> <p>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.</p> <p>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.</p> </div> </div> </div> </section> <section class="icon_boxes hide_none two-columns margin-no-top alignment-top"> <div class="container"> <div class="icon_boxes__content"> <h3>Unrivaled experience and currently supporting:</h3> </div> <ul> <li> <div class="icon_boxes_inner"> <img src="https://www.cryoport.com/wp-content/uploads/2023/12/Cryoport-Systems_Clinical-Trials-Icon-1.svg" alt="Kit Production icon" /> <div class="icon_boxes_content"> <div class="icon_boxes_content_copy"> <h3>691</h3> <p>Active <strong>Cell &amp; Gene Therapy</strong> Clinical Trials</p> </div> </div> </div> </li> <li> <div class="icon_boxes_inner"> <img src="https://www.cryoport.com/wp-content/uploads/2023/12/Cryoport-Systems_Commercialization-Icon-1.svg" alt="DNA icon" /> <div class="icon_boxes_content"> <div class="icon_boxes_content_copy"> <h3>17</h3> <p>Commercial <strong>Cell &amp; Gene Therapies</strong></p> </div> </div> </div> </li> </ul> </div> </section> <section class="column-content standard-content list-style-1 margin-no-top width-full hide_none"> <div class="container"> <div class="standard-content__content"> <h2>A dry ice shipping system designed for complex biotherapeutics</h2> <h4>Overcoming industry challenges for maximum protection of irreplaceable materials</h4> <p>At Cryoport Systems, we understand that the transport of sensitive biospecimens requires a specialized shipping system. Our Cryoport Elite® Ultra Cold Dry Ice Shipping System has been precision-engineered to mitigate risk and ensure the thermal and physical integrity of high-value therapies throughout transit, providing maximum protection of irreplaceable gene therapies.</p> <p>This system has been purpose-built for dry ice shipments, offering industry-leading hold times combined with advances in packaging, informatics, and logistics to deliver exceptional performance. With a holding temperature ranging from -60°C to -80°C, the Cryoport Elite® Ultra Cold shipping system satisfies the requirements for transporting raw materials, viral vectors, and gene therapies. The hold time of 140+ hours not only exceeds industry standards, but also allows for proactive risk mitigation for challenging shipping lanes.<br /> <a class="btn default" href="https://www.cryoport.com/solutions/shipping-systems/cryoport-elite/elite-ultra-cold/" rel="noopener">Explore the Cryoport Elite® Ultra Cold Shipping System</a></p> </div> </div> </section> <section class="column-content content-two-columns standard list-style-1 top reversed hide_none"> <div class="container"> <div class="content-two-columns-1"> <p><img fetchpriority="high" decoding="async" class="alignleft size-full wp-image-9096" src="https://www.cryoport.com/wp-content/uploads/2024/03/TRUST-Graphic_Short_RGB-e1711486506913.png" alt="" width="4857" height="2752" srcset="https://www.cryoport.com/wp-content/uploads/2024/03/TRUST-Graphic_Short_RGB-e1711486506913.png 4857w, https://www.cryoport.com/wp-content/uploads/2024/03/TRUST-Graphic_Short_RGB-e1711486506913-300x170.png 300w, https://www.cryoport.com/wp-content/uploads/2024/03/TRUST-Graphic_Short_RGB-e1711486506913-1024x580.png 1024w, https://www.cryoport.com/wp-content/uploads/2024/03/TRUST-Graphic_Short_RGB-e1711486506913-768x435.png 768w, https://www.cryoport.com/wp-content/uploads/2024/03/TRUST-Graphic_Short_RGB-e1711486506913-1536x870.png 1536w, https://www.cryoport.com/wp-content/uploads/2024/03/TRUST-Graphic_Short_RGB-e1711486506913-2048x1160.png 2048w" sizes="(max-width: 4857px) 100vw, 4857px" /></p> </div> <div class="content-two-columns-2"> <h2>Cryoport Systems is Enabling the Outcome™ through our unparalleled supply chain platform</h2> <p>Cryoport Systems was established by a team of doctors dedicated to serving the life sciences through expert logistics support. Today, our partnership capabilities have evolved beyond logistics into a robust platform of supply chain solutions — including BioServices and Biostorage — that supports every stage and phase of the life sciences research, development, and manufacturing process. Our comprehensive platform of solutions makes Cryoport Systems a standalone vendor that can support all aspects of the temperature-controlled supply chain.</p> <p><a class="btn default" href="https://www.cryoport.com/enabling-the-outcome-gene-therapy/" rel="noopener">LEARN MORE ABOUT HOW CRYOPORT SYSTEMS IS ENABLING THE OUTCOME™</a></p> </div> </div> </section> <section class="related_wrap four-columns margin-no-top hide_none"> <div class="container related_container" data-scroll> <div class="related_intro"> <h4>We have comprehensive solutions in support of the entire gene therapy supply chain. Explore our capabilities and technologies below:</h4> </div> <div class="related_grid"> <div class="card related"> <div class="card_image"> <img src="https://www.cryoport.com/wp-content/uploads/2023/11/ATS-Shippers-copy-e1702062858673.jpg" alt="" /> </div> <div class="card_content"> <h3 class="h4">Shipping Systems</h3> <p><a href="https://www.cryoport.com/solutions/shipping-systems/">Learn More</a></p> </div> <a class="card_overlay" href="https://www.cryoport.com/solutions/shipping-systems/"> Learn More </a> </div> <div class="card related"> <div class="card_image"> <img src="https://www.cryoport.com/wp-content/uploads/2023/11/Transportation-Main-Page-Header_logo.jpg" alt="" /> </div> <div class="card_content"> <h3 class="h4">Transportation</h3> <p><a href="https://www.cryoport.com/solutions/transportation/">Learn More</a></p> </div> <a class="card_overlay" href="https://www.cryoport.com/solutions/transportation/"> Learn More </a> </div> <div class="card related"> <div class="card_image"> <img src="https://www.cryoport.com/wp-content/uploads/2023/11/BioServices-Header.jpg" alt="" /> </div> <div class="card_content"> <h3 class="h4">BioServices</h3> <p><a href="https://www.cryoport.com/solutions/bioservices/">Learn More</a></p> </div> <a class="card_overlay" href="https://www.cryoport.com/solutions/bioservices/"> Learn More </a> </div> <div class="card related"> <div class="card_image"> <img src="https://www.cryoport.com/wp-content/uploads/2023/11/Consulting-Services-Body-4.jpg" alt="" /> </div> <div class="card_content"> <h3 class="h4">Consulting Services</h3> <p><a href="https://www.cryoport.com/solutions/consulting-services/">Learn More</a></p> </div> <a class="card_overlay" href="https://www.cryoport.com/solutions/consulting-services/"> Learn More </a> </div> <div class="card related"> <div class="card_image"> <img src="https://www.cryoport.com/wp-content/uploads/2023/12/tech4med-1.webp" alt="" /> </div> <div class="card_content"> <h3 class="h4">Data Management</h3> <p><a href="https://www.cryoport.com/solutions/data-services/">Learn More</a></p> </div> <a class="card_overlay" href="https://www.cryoport.com/solutions/data-services/"> Learn More </a> </div> <div class="card related"> <div class="card_image"> <img src="https://www.cryoport.com/wp-content/uploads/2024/07/Infographic_Integricell_RGB.png" alt="" /> </div> <div class="card_content"> <h3 class="h4">IntegriCell™ Cryopreservation</h3> <p><a href="https://www.cryoport.com/solutions/integricell/">Learn More</a></p> </div> <a class="card_overlay" href="https://www.cryoport.com/solutions/integricell/"> Learn More </a> </div> </div> </div> </section> <div id="shape_1"></div> <div id="shape_2"></div> <div id="shape_3"></div> </div> </article> </main> <footer class="site-footer" role="contentinfo"> <div class="blue_stats_grid_footer"> <div class="prefooter container columns"> <div class="prefooter-content"> <h3>Subscribe to our newsletter</h3> <h5>Never miss another update! 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