As cell and gene therapies continue to transform modern medicine, Cryoport Systems evolves its products and solutions to meet the needs of the industry and the patients it serves. In 2022, we launched our Global Supply Chain Centers to expand our client offerings with BioServices. Our extensive expertise in temperature-controlled supply chain management made this expansion of services in support of Cell & Gene Therapies a seamless transition. Now in 2023, Cryoport Systems’ Global BioServices are fully launched in the US at our Morris Plains, New Jersey and Houston, Texas Global Supply Chain Centers and in Europe, at Cell&Co, a Cryoport Company, in Clermont-Ferrand, France.
We’ve established our BioServices offerings at state-of-the art facilities with compliance, quality and efficiency in mind. Cryoport Systems BioServices can help therapy developers manage the storage, packaging, and distribution of their therapeutic products and other GMP materials as well as providing additional services pertinent to the industry. Our facilities in the US and Europe offer the following services:
All our facilities provide secure, GMP-compliant, controlled-temperature storage. All storage equipment is validated, with comprehensive temperature monitoring, redundant infrastructure, backup storage units, and on technicians on-call 24/7/365.
Our GMP-compliant storage supports the following temperature ranges:
- Controlled Room Temperatures (15-25°C)
- Refrigerated (2-8°C)
- Frozen (-20°C)
- Ultra-cold (-80°C)
- Cryogenic (<-150°C)
Packaging and Labeling
GMP-compliant secondary packaging and labeling of drug products and other materials is a crucial service provided by our BioServices offering. This service is required for cell and gene therapy products in order to protect delicate cryogenic and ultra-cold primary storage containers and to provide essential information on the packaging according to regulatory requirements. Our solutions include options for all formats of primary container, and we can also provide custom secondary packaging designed by our Packaging Center of Excellence. The BioServices team ensures that each order is tailored to meet the study protocol and clinic identification requirements.
Our packaging and labeling solutions encompass:
- Packaging and label design
- Validated translation service
- Tamper evident seals
- 1D & 2D barcoding
- In-house panel label printing
- Packaging and labelling down to cryogenic temperatures
- Just-in-time services
Drug Recall, Return and Destruction
We can manage the recall, return and destruction of all clinical supplies at the end of, or during a clinical trial. Our highly trained team will handle services concerning returns, reconciliation, and certified destruction by GMP/GCP compliant procedures.
This service handles all aspects of the return process like:
- Personal coordination with the investigations site and study team
- Temporary quarantine storage
- Certificate-provided destruction via approved vendors
- Temperature-controlled return shipments
- Custom return kits
Our kit production service offers complete customization. This service involves the assembly and distribution of kits such as apheresis, blood/tissue collection, manufacturing, drug administration, and more.
Kit production services includes:
- Kit design services
- Component procurement
- Inventory management
- Document printing
Texas, New Jersey, and France are just the start of our Global BioServices locations. We will continue to grow our reach, internationally, to help therapy manufacturers and patients around the world. Cryoport Systems is excited to pursue our BioServices efforts to support life and health through its advanced technologies, dedicated personnel and commitment to quality. Learn more about our BioServices on our BioServices webpage.