Biological Activity of serum as a culture supplement

Clinical information

Diagnostic utility:

Serum is a culture supplement that provides necessary factors for the growth and expansion of cell lines in culture.

Evaluation of its biological activity is used as a quality control for this supplement in both research projects and the manufacturing of advanced therapy medicinal products.  

Method: 

Luminescence

Reference values

The results are quantitative and must meet the following acceptance criteria:

Diagnostic algorithm:

Not applicable.

Response time:

21 natural days

Specimen information

Sample: Inactivated human serum from groups B and AB.
Tube: Additive-free tube
Minimum volume: 5 mL
Stability: Cryopreserved between -30±10^oC: 30 months
Transport instructions: Frozen inactivated human serum samples.

Reason for rejection:

• Inactivation time ≥6 months from serum collection
• Thawed samples ≥12 hours

Administrative information

BST Code: CEL024
Test Description: Serum Biological Activity as a culture supplement.
Synonyms: Serum Biological Activity
Section: Cellular Laboratory
BST Rate: Check the updated rates here.

Profiles:

N/A

References

• Lange, C., et al., Accelerated and safe expansion of human mesenchymal stromal cells in animal serum-free medium for transplantation and regenerative medicine. Journal of Cellular Physiology, 2007. 213(1): p. 18-26.
• Pérez-llzarbe M et al. Comparison of ex vivo expansion culture conditions of mesenchymal stem cells for human cell therapy. Transfusion. 2009 Sep;49(9):1901-10.
• Bieback K et al. Human alternatives to fetal bovine serum for the expansion of mesenchymal stromal cells from bone marrow. Stem Cells. 2009 Sep;27(9):2331-41.
• NCF Parte IV: Directrices sobre normas de correcta fabricación específicas para Medicamentos de Terapia Avanzada.