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Provision of fresh hematopoietic cells

PRG035

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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).

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 rigid containers, validated to maintain the transport temperature according to particular specifications. They must prevent liquid leakage and pressure changes.

If frozen temperature accumulators are used, they should not be in direct contact with the product.

Transportation will be entrusted to specifically trained and qualified personnel.

They should not be x-rayed.

Reference values

The transport temperature should be between 2 and 8 °C.

Specimen information

Product: provision of fresh HPC.

Tube: not applicable.

Volume: depends on the type of product (apheresis or bone marrow), and the handling to which it has been subjected.

Shelf life: 72 hours.

Transport instructions: 2-8 °C.

Storage instructions: 2-8 °C.

Administrative information

BST code:  PRG035

Test description: when a HPC product is distributed with no need for cryopreservation.

Synonyms: Fresh HPCs.

Section: Cell Therapy Service. Cell Therapy Laboratory.

Service: when a HPC product is distributed with no need for cryopreservation, fee PRG035 applies. In general, these products are used in allogeneic transplants and may be associated with a fee for procurement (if performed at the Blood and Tissue Bank (BST)), receipt and control, and some processing, if requested. The fee includes product release quality controls and transport to the hospital.

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.

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