Clinical information
Clinical utility
In the case of autologous hematopoietic progenitor cell transplantation (HPCT), and in some allogeneic HPCT, the hematopoietic progenitor cells (HPC) must be frozen before use.
Thawing is a critical step to ensure the safety and efficacy of the HPCT.
Method
Before starting the thawing process, the integrity of the bag should be carefully checked. Frozen HPCs are placed inside a safety bag and immersed in a wet thawer with sterile water at 37°C. During thawing, the bag is massaged and removed from the bath just before the crystals disappear.
Dry thawers can also be used for thawing frozen HPCs.
In the case of several bags, time should be allowed between bags to evaluate the occurrence of adverse reactions.
Thawing is carried out in the local blood banks of each hospital, in areas designated for this purpose.
Reference values
The product thawing time should not exceed 12 minutes.
Specimen information
Product: Thawed HPC.
Tube: not applicable, except in the case of validation or verification of cryovial results.
Volume: 20-80 ml in the case of advanced therapy medicinal products (ATMPs). Less than 150 ml in the case of HPC.
Shelf life: 30 minutes in the case of ATMP. 60 minutes in the case of HPC.
Transport instructions: between 2 and 8 °C.
Storage instructions: not applicable.
Administrative information
BST code: BT401.
Description of the test: cryopreserved products should be thawed in rapid thawing systems (dry systems or water baths).
Synonyms: Thawed HPC.
Section: Regional Blood Bank. Cellular Therapy Service (Cellular Therapy Laboratory).
Service: this fee (BT401) includes this processing (usually performed in hospital Blood and Tissue Banks (BST), but may also be performed at the BST-FDJ) as well as internal transport from the blood bank area to the patient's bedside.
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.
