Quantification/Viability of Mesenchymal Cells

Clinical information

Diagnostic Utility:

This test quantifies the concentration and viability of mesenchymal cells from fresh cultures or thawed products. It is used for quality control of Advanced Therapy Medicinal Products (ATMPs) as well as for the evaluation of cultures/products in the research phase. Mesenchymal cells can originate from bone marrow, Wharton's jelly from the umbilical cord, amniotic fluid, etc.

Method: 

Flow Cytometry.

Reference Values

The results are quantitative. The expected values for cell concentration vary greatly depending on the culture status or the manufacturing control point of the cellular product. The expected viability value is above 70%.

Diagnostic Algorithm:

Not applicable.

Turnaround Time:

1 day.

Specimen information

Sample: Mesenchymal cell cultures in fresh or thawed products.
Tube: Additive-free tube
Minimum volume: 300 µL

Stability:

• Fresh sample: 1 day
• Thawed samples: 1 hour

Transport instructions: room temperature.

Reason for rejection: Sample with clots.

Administrative information

BST Code: CEL015
Test Description: Quantification of concentration and viability of mesenchymal cells.
Synonyms: R/V MSCs
Section: Cell Laboratory
BST Rate: Check the updated rates here.

Profiles:

The CEL015 test Quantification/Viability of Mesenchymal Cells can be requested alone. It is also performed within the following profiles:

References

Codinach M et al.; Design and validation of a consistent and reproducible manufacture process for the production of clinical-grade bone marrow-derived multipotent mesenchymal stromal cells; Cytotherapy, 2016, 18-9, pp.1197-1208.

Quality

BST holds ISO 9001, ISO 14001, and OSHAS 18001 quality certifications, as well as the European Excellence 500+ seal. BST is accredited by CAT, JACIE-FACT, FACT-NETCORD, and EFI, and complies with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidelines.