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Receipt and control of hematopoietic cells

PRG036

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Clinical information

Clinical utility

To ensure that hematopoietic progenitor cells (HPCs) and mononuclear cells (MNCs) meet minimum requirements for use, e.g. for transplantation or processing, the products must be characterised upon receipt.

Method

The following should be determined on HPCs and MNCs upon receipt:

- Quantification, enumeration and viability: It is extremely important to determine the number of cells, subsets and their viability with cytometric techniques to evaluate the quality of the products and to rule out damage during collection.

- Function and potency: in vitro potency tests are surrogate markers of in vivo potency.

- Identification: verification of labelling ensures product traceability.

- Microbiological contamination: to reduce the risk to patients, the sterility of the products must be verified.

Reference values

Viabilities above 95% in the case of apheresis, > 90% in the case of bone marrow or cord blood.

Specimen information

Product: not applicable.

Tube: not applicable.

Volume: depends on the type of product.

Shelf life: depends on the type of product.

Transport instructions: depends on the type of product.

Storage instructions: depends on the type of product.

Administrative information

BST code: PRG036.

Description of the test: product screening and testing tasks, application registration, labelling, etc., and quality controls (cell and progenitor cell counts, cell viability, etc.) that are applied to all products received in the laboratory.

Synonyms: not applicable.

Section: Cell Therapy Service. Cell Therapy Laboratory.

Service: fee PRG036 includes the cost of processing (product screening and testing, application registration, labelling, etc.) and quality controls (cell and progenitor cell counts, cell viability, etc.) that are applied to all products received in the 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.

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