Cryoport Global BioServices

Storage

Secure, GMP-compliant, controlled-temperature storage at the following temperatures:

• Controlled Room Temperature (15-25˚C)
• Refrigerated (2-8˚C)
• Frozen (-20˚C)
• Ultra-cold (-80˚C)
• Cryogenic (<-150˚C)

All storage in validated equipment with full temperature monitoring, redundant infrastructure, backup storage units, and on-call technicians.

Packaging & Labeling

Secondary packaging and compliant labeling of drug product and other materials:

• Packaging and label design
• Validated translation
• Tamper evident seals
• Labeling down to Ultra Low
• Packaging down to Cryogenic

Regulatory & QP Services

Our EU locations will provide Qualified Person (QP) oversight of import and release as required by EU Clinical Trials Directive 2001/20/EC and Annex 13 of EU GMP Guide: 

• Manufacturing batch review
• Batch release
• Pass-through depot for urgent shipment requests
• Consulting services concerning regulatory requirements
• EU QP audits of manufacturing/testing facilities
• QP Declaration
• Trade compliance guidance

Drug Return & Destruction

We handle all aspects of the return process, including:

• All required services concerning returns, reconciliation, and destruction by GMP/GCP complaint procedures
• Coordination with the investigational site and study team
• Temporary quarantine storage
• Destruction certificates provided
• Temperature-controlled returned shipments where required

Kit Production

Production and distribution of all types of kits (including apheresis, blood/tissue collection, manufacturing, drug administration, etc).

• Kit design services
• Component procurement
• Inventory management
• Labeling
• Distribution