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 Trails 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?

BioServices will be introduced at select current and future Cryoport Logistics Centers.
Morris Plains, New Jersey
Houston, Texas

Additional locations to be announced in the near future.

 

When will it be available?

We expect the Houston and Morris Plains facilities to be operational by the end of Q2 2021

Questions?

If you have any questions or want more information, please fill out the form below
or email Rob Jones, VP of Global BioServices at rjones@cryoport.com.

REQUEST MORE INFORMATION

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