Determination of Endotoxins
Code: CEL028
Type: Control de qualitat de medicaments de teràpia avançada
Clinical information
Diagnostic Utility:
Endotoxins are toxins associated with the outer membrane of some bacteria. Specifically, endotoxins are a fraction of the lipopolysaccharide in the outer cell wall of Gram-negative bacteria. Endotoxins are not secreted but are released when bacterial cells undergo disruption. They are less specific than exotoxins, but in large quantities they can cause fever, stimulation of the innate immune system, hemorrhage, activation of the coagulation cascade, and toxic shock. Due to their effects, it is important to ensure that cellular products are not contaminated with endotoxins before releasing them for use.
This endotoxin detection test is based on a kinetic colorimetric assay approved by the European Pharmacopoeia (method D) and provides quantitative results.
Method:
Kinetic colorimetric assay approved by the European Pharmacopoeia read by spectrophotometry.
Reference Values
The results are quantitative and are expressed in EU/mL. The expected values depend on the product being analyzed. Results should be below the maximum specifications set for each product.
Diagnostic Algorithm:
Prior to determining endotoxins for the first time in a product type, prior validation should be performed to ensure that the product does not interfere with the endotoxin detection method. In case of interference, the working dilution at which the product is neither an inhibitor nor an activator must be determined. The endotoxin validation test (CEL0029) analyzes different dilutions of the product to determine which is most suitable for analysis.
| Code | Test Name | Can it be ordered separately? | Is it always done? |
|---|---|---|---|
| CEL0029 | Previous Validation of Endotoxin Determination | Yes |
No Must be done the first time a new product is tested. |
Response Time:
1 day.
Specimen information
Sample: sterile sample of fresh or thawed cell therapy product.
Tube: Additive-free tube free of endotoxins
Minimum volume: 100 µL.
Stability: 1 day
Transport instructions: Room temperature.
Reason for rejection: Sample poorly identified.
Administrative information
BST Code: CEL028
Test Description: Endotoxin determination.
Synonyms: Endotoxins
Section: Cell Laboratory
BST Fee: Check the updated fees here.
Profiles:
N/A.
References
- The Endosafe PTS User's Guide
- Guia de Normas de Correcta Fabricación de la Unión Europea para medicamentos de uso humano
- Farmacopea Europea