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Global Experts in Temperature-Controlled Supply Chain Management for Gene Therapies
Cryoport Systems is your strategic partner for comprehensive solutions that protect high-value gene therapies throughout the supply chain
Our comprehensive platform of cutting-edge solutions is designed to mitigate risk and instill certainty at every juncture of your gene therapy supply chain.
Our patented, innovative shipping systems, comprehensive transportation solutions, and integrated BioServices and biostorage capabilities, coupled with bespoke consulting services to seamlessly navigate packaging and shipping qualifications and shipping risk assessments, makes Cryoport Systems your pillar of support across all facets and stages of gene therapy research, development, and manufacturing.
- Diverse Fleet of Shipping Systems: Compliant Gene Therapy Shipping
Our diverse line of robust shipping systems enables compliant shipping of gene therapy materials worldwide. - Full-Scale Supply Chain Provider: An Entire Platform of Solutions
We are a single-source vendor that can support all aspects of the temperature-controlled gene therapy supply chain – from biostorage to drug labeling to distribution. - Risk Mitigation: Providing Certainty at Every Stage and Phase
Our purpose-built solutions and services are proactively designed to mitigate risk for researchers, developers, and manufacturers. - Scalability: Comprehensive services for certainty in your supply chain
Our capabilities continue to evolve to meet the needs of the gene therapy market both today and into the future.
Enabling the Outcome™ for viral vector and gene therapy research, development, and manufacturing
Making Gene Therapy Supply Chain Management as Easy as 1, 2, 3
1. Full-Scale Supply Chain Platform within a Single Vendor Relationship
Our supply chain management support encompasses an entire platform of risk-mitigating solutions — including biostorage, drug labeling and distribution — 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.
2. Superior Risk Mitigation at Every Stage
Our purpose-driven solutions are designed to proactively mitigate risk throughout every stage and phase of the gene therapy supply chain to support certainty for researchers, developers, and manufacturers. From uniform operating procedures across our global facilities to developing the industry’s most innovative shipping systems, our advanced and patented technology is unrivaled in risk-mitigation, offering peace of mind to those to trust Cryoport Systems with their often irreplaceable, lifesaving therapies. We developed the industry’s only requalification process to inspect and requalify every shipper, every time, and our team was involved in developing ISO 21973 (General Requirements for Transportation of Cells for Therapeutic Use) – which have become a pillar of our services at every location.
3. Scalable Solutions to Support Therapeutics from Research to Commercialization
Our capabilities have evolved beyond logistics into a robust platform of supply chain solutions such as biostorage and drug labeling that support the entire lifecycle of gene therapy research, development, manufacturing, and commercialization. We’ve supported 650+ clinical trials and have delivered more than 800,000 shipments of sensitive and often irreplaceable materials across the globe. Our continued growth and expansion is scaling to support the anticipated 1.5M+ commodities a year, adding certainty to the entire supply chain while creating tailored solutions that fit specific needs at every phase. Our vast experience extends to all aspects of client activities from pre-clinical to commercial, and our platform solutions support the scalability and evolution of gene therapy clients and their complex and changing objectives.
Unparalleled scope of robust supply chain management solutions and trusted logistics for gene therapies
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Shipping Systems for Various Temperatures
Our shipping systems support various temperature requirements for gene therapies and adhere to ISO 21973 requirements – the highest compliance standard for Transportation of Cells for Therapeutic Use.
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Transportation, Logistics, and Tracking
We have transported more than 800,000 sensitive material shipments across a wide range of temperature bands. Our innovative logistics management system provides access to 24/7/365 monitoring and tracking.
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BioServices and Biostorage
Our BioServices and Biostorage solutions support the intricacies and commercial material management. Our global network supports GMP storage, drug packaging and labeling, kit production and distribution to drive efficiency and scale.
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Customizable Consulting Services
Cryoport Systems’ Consulting Services have the capacity to evolve with the stages of your gene therapy operation. From shipping risk assessments to packaging qualifications, we support companies through all phases to clinical and commercial development.
Shipping Systems for Various Temperatures
Our diverse line of robust shipping systems enables compliant shipping of viral vectors and gene therapy materials from anywhere in the world with the certainty that the transported commodity will arrive with its full integrity intact. We have successfully transported more than 800,000 sensitive materials across a wide range of temperature bands and provide a 100% requalification process. Our unique requalification process ensures each of our shipping systems maintain full integrity throughout a shipping journey to protect the overall integrity of shipped gene therapies and viral vectors.
Our Chain of Compliance® process provides complete traceability of all shipments in the Cryoport Systems shipping fleet, enabling us to stand at the forefront of compliance and traceability. We track the equipment and processes used in managing the biomaterials with serialization the shippers and components. Not only do we log the performance history of the shipper and courier, but we maintain complete temperature records of transported materials for at least 10 years alongside an extensive historical data depository to help guide risk-based decision making.
No matter the material type or shipping system used, all of our shippers adhere to ISO 21973, General Requirements for Transportation of Cells for Therapeutic Use. This is the highest compliance standard that exists within the life sciences industry, and our adherence to this standard for every shipment, every time ensures that your irreplaceable materials are transported safely and securely.
Cryoport Elite® Shipping Systems
The Cryoport Elite® Ultra Cold shipping system was custom-engineered for safe and secure shipping on dry ice at -60 to -80°C using a revolutionary shipping system that was purpose-built for cell therapies, gene therapies, viral vectors, and valuable biologics. With industry-leading hold times over 140+ hours and a customizable payload holding system, the Cryoport Elite® Ultra Cold shipping system delivers exceptional performance for irreplaceable materials.
Cryoport Express® Shipping Systems
Our Cryoport Express® shipping systems include liquid nitrogen dry vapor units for shipping at -150°C and phase change shippers for shipping at either 2-8°C or 15-25°C. These reusable and recyclable shipping systems are meticulously engineered for cost-effectiveness and dependability.
Transportation of Viral Vectors & Gene Therapies
When it comes to specialized shipping of sensitive, high-value materials like viral vectors and gene therapies, our transportation services can be trusted every step of the way. We provide safe, secure transportation of commodities across temperature bands – including cryogenic, ultra-cold (dry ice), refrigerated, and controlled room temperature. Whether you’re moving a single dose of an advanced therapy across town or you’re shipping an entire fleet of sensitive material from one country to another, we are able to manage the logistics of transporting your commodities with their integrity intact.
Additionally, our Cryoshuttle® pickup and delivery service provides local transportation for sensitive materials within proximal distance of our Global Logistics Centers and Global Supply Chain Centers. Whether you’re shipping domestically or globally, we can accommodate your temperature-controlled supply chain needs.
Comprehensive Tracking & Informatics
At Cryoport Systems, we incorporate state-of-the-art informatics and data monitoring technology into our shipping systems to provide near real-time traceability. When it comes to track & trace capabilities for your irreplaceable viral vector or gene therapy, precision, reliability, and efficiency are non-negotiable. Cryoportal® 2 is the industry’s most innovative logistics management system that consolidates a shipment’s inventory, ordering, tracking, documents, and reporting into a single interface. With access to 24/7/365 monitoring, comprehensive visibility, and meticulous traceability of the entire transport process, you can view and manage all order information at-a-glance.
In conjunction with our Smartpak® II condition monitoring system, you gain visibility into near-real time data about a shipments internal and external temperature, orientation and tilt, location, and other critical metrics for ensuring the integrity of your shipped materials.
BioServices & Biostorage
We’re proud to introduce our BioServices and Biostorage solutions at our Global Supply Chain Centers. These state-of-the-art facilities combine our existing logistics processes and capabilities with our new, cutting-edge Bioservices infrastructure all under one roof.
We’ve designed this new and integrated approach to support gene therapy manufacturing and development. This includes comprehensive controlled-temperature storage, fulfillment, drug packaging, labeling of therapeutic products, and storage of GMP raw materials all in addition to our world-class logistics.
Customizable Consulting Services
Complex biologics and gene therapies need a robust, temperature-sensitive supply chain. These chains are often more complex than a normal supply chain. With our consulting services, you have an expert at hand who is full of crucial advice and knowledge and who can quickly spot and solve any risks in your temperature-controlled supply chain and logistics. We tailor solutions that deliver value and insight, with robust solutions that are customizable to your stage of development. Whether you are pre-IND or post-commercial, we work with you to tailor a solution that meets your needs, timelines, and budget. Our offerings include shipping risk assessments, shipping lane validations, shipper/packaging qualification, custom packaging/accessory design, data services, and more.
Supporting certainty through our risk-mitigating supply chain expertise — one patient, one therapy, one product at a time.
Download the ISO 21973 Whitepaper
This white paper discusses key recommendations and changes that interested parties should review and evaluate when planning their clinical and commercial distribution strategies for cell and gene therapies.
Global Compliance, Local Presence
We have created a platform of temperature-controlled supply chain solutions that consistently meet or exceed industry standards.
At Cryoport Systems, we are driving standardization to address the critical complexities related to the collection and processing of patient material, mitigating risk at every stage. Our experts have contributed to developing ISO standards, such as ISO 21973, to help drive best practices in the industry. We work closely with ISTA, IATA, ASTM, and other internationally accredited organizations. We are also diligently involved with the Foundation for the Accreditation of Cellular Therapy (FACT) and the Standards Coordinating Body (SCB).
Our operating procedures are uniform across all of our facilities, ensuring consistent support across all stages and phases of your journey regardless of which global Cryoport Systems location you’re working with.
We stand at the forefront of complete traceability in the supply chain, with complete temperature records of transported materials maintained for at least 10 years and an extensive historical data depository to help guide risk-based decision-making. Our Cryoportal® Logistics Management System is the industry’s only system with validated compliance to 21 CFR Part 11 and ISPE GAMP5.
You can TRUST our comprehensive and integrated supply chain platform to Enable Your Outcomes™
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At Cryoport Systems, we are purpose-built for robust, comprehensive solutions with a longstanding dedication to quality.
We lead the way in temperature-controlled expertise for supply chain support with agile, flexible solutions that meet your needs. Our consistent risk mitigation, from our proprietary Veri-Clean® process to our robust requalification procedures, means we are the only provider to requalify our shippers – every shipment, every time. We stand at the forefront with unparalleled traceability, thanks to our Chain of Compliance® for full traceability in managing the distribution of irreplaceable commodities. We offer scalability with an expanded depth of services – such as BioServices and biostorage – that add certainty to your supply chain with tailored solutions that fit your needs. With 650+ clinical trials supported and more than half a million successful shipments of sensitive – and often irreplacable – materials across the globe, you can count on our track record of success that spans decades.