BioServices Infographic updated 21DEC2020

What is it?

storage

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.

New-Labelling-Image-BioServices-1

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 and QP Services

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 and Destruction

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

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

Where will it be?

Cryoport BioServices is currently available at our Morris Plains, NJ & Houston Texas Global Supply Chain Centers. Additional locations to be announced in the near future.

Explore our Houston Global Supply Chain Center with this animated tour:

 

Check out our Morris Plains Global Supply Chain Center with this animated tour:

 

Questions?

If you have any questions or want more information, please fill out the form below.

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Cryoport® is a trademark of Cryoport, Inc. and used with permission by Cryoport Systems, LLC