Sterile products

LAL test and recombinant factor C test

To date, the Limulus Amebocyte Lysate test, or LAL test for short, is the most sensitive and specifically effective method for the detection of endotoxins and is internationally accepted (Ph. Eur. 2.6.14, USP <85>, USP <161> and JP 4.01). At Labor LS, our customers have access to a broad spectrum of methods within the scope of LAL tests. The following methods are established at Labor LS:

  • gel clot method (methods A and B),
  • kinetic turbidimetric method (method C) and
  • kinetic chromogenic methods (method D)

With these four established test methods, Labor LS has achieved an optimal range of methods. At the customer's request, we perform a product-specific matrix validation of the LAL test for the test method(s). In addition to product testing of pharmaceuticals, biopharmaceuticals, in-process controls and raw materials, Labor LS also offers comprehensive study designs in the field of endotoxin testing.

 

recombinant factor C test

For the rFC test, Labor LS uses the ELISA-based EndoLISA® test kit from Hyglos for the detection and quantification of endotoxins. This new option of testing for bacterial endotoxins is an alternative test method to the pharmacopoeia methods of the LAL test. The EndoLISA® test system offers new possibilities in sample processing both for product matrices that interfere strongly with the LAL test as well as for pharmaceutical formulations. The EndoLISA® test design offers new solutions, particularly with regard to the phenomenon of Low Endotoxin Recovery (LER), to counter product-related masking of endotoxins and to create test conditions that exclude potentially false negative results in the context of release analytics.

Your contacts on this topic

We would be pleased to advise you and prepare an individual quotation for you! For more information and enquiries, please contact our team of experts:

Dr. Enrico Barth
Examination of bacterial endotoxins
+49 9708 9100-462
enrico.barth@labor-ls.de

Jacqueline Dünisch
Examination of bacterial endotoxins
+49 9708 9100-192
jacqueline.duenisch@labor-ls.de