Clinical information
Clinical utility
The safety of the hematopoietic progenitor cells (HPCs) supplied is essential to ensure the efficacy of hematopoietic progenitor cell transplantation (HPCT). When frozen, delivery can be made before patient conditioning begins
HPCs should be supplied in containers that ensure the integrity of the product and the safety of transport personnel.
Method
Fresh HPCs are supplied in gas-phase nitrogen containers (dry shipper), designed to maintain cryogenic temperatures (< -135 °C).
These containers are filled with liquid nitrogen; they absorb the nitrogen with an inner sponge and release it in the gas phase. Handling of the product will be carried out by trained personnel.
Their autonomy is 10 to 14 days. They have continuous temperature control.
They should not be x-rayed.
Reference values
The transport temperature must be below -135 °C.
Specimen information
Product: provision of cryopreserved HPC.
Tube: not applicable.
Volume: less than 200 ml.
Shelf life: 10-14 days.
Transport instructions: 135 °C.
Storage instructions: not applicable.
Administrative information
BST code: BT780
Description of the test: applies when the product to be administered is distributed cryopreserved.
Synonyms: Cryopreserved HPC.
Section: Cell Therapy Service. Cell Therapy Laboratory.
References
Areman, E. M.; Loper, K., editors. Cellular therapy: Principles, methods, and regulations. 2nd ed. Bethesda (MD): AABB Press, 2016.
Quality
The BST has ISO 9001, ISO 14001, OSHAS 18001 and European Seal of Excellence 500+ quality certifications. The BST is accredited by CAT, JACIE-FACT, FACT-NETCORD and EFI. It complies with the guidelines of good manufacturing and good distribution practices.
