BioServices solutions to solve industry challenges
A global network of flexible, integrated services that help drive efficiency and scale
Cryoport Systems was established specifically to serve the life sciences through expert logistics support. Today, our partnership capabilities have evolved beyond logistics into a robust platform of supply chain solutions that encompasses a suite of BioServices – including controlled temperature, GMP-compliant storage, fulfillment, kit production, secondary packaging, labelling of therapeutic products, and storage of GMP raw materials – all in addition to our world-class logistics.
Our BioServices solutions work to solve industry challenges by cutting facility costs and helping to drive efficiency and scale while allowing our clients to devote more of their efforts toward the discovery, development, manufacturing, and delivery of personalized therapies to treat their patients around the world.
Integrated BioServices for cell and gene therapies
Expanded biomaterials management capabilities encompass every aspect of the supply chain for the discovery, development, and delivery of cell and gene therapies
Cryoport Systems has expanded our risk-mitigating supply chain platform to include integrated BioServices solutions that are designed to directly support the intricacies of cell and gene therapy clinical trials and commercial material management. Our global network of BioServices solutions include GMP storage, drug packaging & labeling, kit production, biobanking, drug recall, return, & destruction, regulatory services, and clinical sample management.
Risk-Mitigating Supply Chain Platform
Our global BioServices solutions expand our flexible and scalable biomaterials management capabilities to every aspect of the supply chain. With a wide range of specifically-tailored services, our expert teams closely collaborate with our clients to develop a customized strategy to store, receive, distribute, and manage precious biomaterials – both upstream and downstream – from the initial stages of raw or starting cellular materials and extending all the way through manufactured therapies with the end goal of patient delivery supported by Cryoport Systems.
We are building a global nexus of BioServices operations strategically located within our Global Supply Chain Network (GSCN) to proactively respond to the specialized needs of the clinical and commercial advanced therapy industry in the United States, EU, and APAC regions. Each facility within our GSCN is outfitted with temperature monitoring, automated alerts, and backup equipment for peace of mind and risk-mitigation of unforeseen events to protect patient material. We can efficiently store, manage, and distribute advanced therapies with greater control, all from a consolidated location.
Our global BioServices solutions have complete traceability with end-to-end chain of identity, chain of custody, and chain of condition with our full-scope Chain of Compliance® to meet the most rigorous quality standards. Our robust quality standards and processes have supported over 650 clinical trials and have played a significant supporting role in the commercialization of over a dozen advanced therapies. Our rigorous processes uphold GMP and GDP requirements for the transportation, storage, and handling of vital biomaterials for cell and gene therapies, and our global facilities hold ISO 9001:2015 certifications and adhere to ISO 21973 standards for the transportation of cells used in therapy. We are also registered with the FDA for HCT/Ps per CFR 1271.
Controlled Temperature Storage
Our comprehensive and custom BioServices solutions include GMP-compliant biobanking and controlled temperature biostorage, which provides the support required to centralize and store client research collections, biological specimens, clinical trial materials, and commercial therapies while adhering to the proper compliance protocols for a range of materials at all temperatures and term durations.
We offer secure, GMP-compliant controlled temperature storage for pre-clinical, clinical, and commercial materials at all temperatures, including controlled room temperature (15-25°C), refrigerated (2-8°C), frozen (-20°C), ultra-cold (-80°C), and cryogenic (<-150°C) storage. We are able to store biomaterials in dedicated or communally-shared units, and our Inventory Management System is fully FDA 21 CFR Part 11 compliant. All activities – including receiving, quality checking, storage, fulfillment, packaging, and shipping – are documented in line with GMP requirements with full traceability throughout the entire supply chain.
Biobanking
Biobanking
We offer biobanking for secure management and storage of preclinical and research specimens in a GMP-compliant environment under strict surveillance and 24/7 on-call personnel who have been trained for all eventualities. Our biobanking IT solutions and data management are validated to industry standards for the utmost reliability. Our technological capabilities include consistent tracking of data across every stage of the sample life cycle and custom reports generated to meet the unique requirements for clinical programs.
Our biobanking systems maintain a consistent temperature of all samples throughout their entire life cycle, ensuring the preservation of their integrity and traceability. Our services align with industry standards, including GMP, GCP, GCLP, ISO 20387, and ISO 9001. By adhering to pharmaceutical regulatory requirements, our services meet the risk management demands specific to the life sciences industry.
Regulatory & Qualified Person (QP) Services
Our EU locations provide Qualified Person (QP) oversight of import and release (as required by EU Clinical Trials Directive 2001/20/EC) with experts who can navigate the complex regulatory environment of European clinical trial applications. These services work to expedite the smooth transportation of irreplicable clinical and commercial samples across borders, offering expert guidance and peace of mind to our clients that their materials are handled compliantly throughout their journey.
Our QP employees facilitate oversight of import and release as required by EU Clinical Trials Regulation 536/2014 according to Annex16 of the EU GMP Guide. This can include pass-through depot for urgent shipment requests, consulting services concerning regulatory requirements, EU QP audits of manufacturing and testing facilities, issuance of QP Declaration, certification of drug products, and importation of pharmaceutical products.
Drug Packaging and Labelling
Our global BioServices capabilities include custom kit production and the packaging and labelling of drug products and other materials at the appropriate temperature to meet the requirements of your study protocol, ensuring that your product does not experience any temperature deviation when processed for shipping.
Our packaging and compliant labelling proficiencies include custom packaging, multi-format, just-in-time, multi-languages, over labelling, tamper evident seals for all temperatures, and more. Our qualified, single-panel labels are printed in-house and can accommodate just-in-time printing. Our clinical packaging and labelling services adhere to cGMP and EU GMP regulations, ensuring compliance with 21 CFR and Annex 13 requirements.
Kit Production
We can procure all the components that go into a custom kit, including blood collection tubes, needles, single-use shippers, saline, and more. Our specialized and custom kit design, production, and distribution services are conducted in-house and can be created for collection kits, manufacturing, drug administration, and shipping. Our processes meet regulatory standards of compliance and are concordant to a client’s specific clinical protocol.
Clinical Sample Management
Our European facility offers clinical sample management and central laboratory services that ensure the activities of pharmaceutical and biotechnology companies are closely aligned with the specific demands of their unique operations. These services facilitate seamless coordination with managing service providers while collaborating with all stakeholders involved in clients’ clinical trials such as trial centers, carriers, laboratories, and monitoring CROs.
Our clinical sample management services include patient sample processing, testing, storage, and real-time monitoring to provide the centralized management for a well-orchestrated flow of operations. We offer the centralized coordination of logistics flows, samples, and third-party labs with the added value of IT and data management with our Laboratory Information Management System (LIMS). Our clinical sample management capabilities leverage import/export authorizations, documentation, traceability, and a dedicated team for sample management operations design.
