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
Labor LS uses a recombinant Factor C–based method (rFC test) for the detection and quantification of endotoxins. This approach represents a compendial alternative to the LAL methods described in the Ph. Eur.
By eliminating raw materials of animal origin, the rFC test contributes to the implementation of the 3R principle - especially in terms of Replace - and supports the establishment of resource-efficient and ethically responsible testing strategies.
