Fact Sheet
BactToxins EP-R - Endotoxin Testing
Interest Group
ATMP manufacturer, pharmaceutical industry, media manufacturer.
Description
The BactToxins EP-C service is performed using fluorogenic recombinant Factor C (rFC) according to EP 2.6.32, an alternative animal free method with no need for Limulus amebocyte lysate (LAL). In addition to this benefit, rFC has low LOT to LOT variability and is not activated by glucan. By default, up to three dilutions of the sample are measured in duplicate, and the assay provides fast and reliable test results.
Recommended Sample Material
Cell cultures, cryo-stocks, sera, antibody formulations, autologous material and many more.
Method
Fluorogenic test method (Endpoint) according to EP 2.6.32 via plate reader.
Applied endotoxin testing system
Pyrogene (Lonza).
Process Control
Controls according to pharmacopoeia (Spike-in, blank, additional control: positive control).
Sample Volume per Assay
90 µl in duplicate per dilution, three dilutions included.
Average Turnaround Time
24 to 48 hours after sample receipt, express testing scheme* possible.
Sensitivity of Method
0.005 EU / ml.
Regulatory Compliance
EP 2.6.32 compliant. Please note, an individual validation is required for LOT / Batch release to demonstrate the efficiency of the analytical procedure in regarding your matrix. Please contact us for further information.
Sample Requirements
Order No.
Endotoxin Testing ‘BacToxins EP-R’ 47-1003
Volume Discount Available
Yes, on request.
Additional Information
Please note: repetitions which are not caused by our laboratory and *express testing schemes are subject to additonal charges. Please contact us for further information.