Biological Activity of serum as a culture supplement
Code: CEL024
Type: Control de qualitat de medicaments de teràpia avançada
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:
| Acceptance criteria | |
|---|---|
| Doubling time | ≤2.1 days |
| Historical doubling time | ±2 SD |
| Growth rate | ≥0.33 days |
| Exponential growth phase time | ≥5 days |
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±10oC: 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 cel/s 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 ce// therapy. Transfusion. 2009 Sep;49(9):1901-1O
Bieback K et al. Human altematives to fetal bovine serum for the expansion of mesenchymal stromal cel/s from bone marrow. Stem Cells. 2009 Sep;27(9):2331-41.