Detection of endotoxins level (LAL test)

In order to guarantee sterility for advanced therapy products in accordance to international guidelines (EU 6.0., 2.6.14, EMEA/CHMP/410869/2006 and USPC chapter 85), one of the parameters that need to be monitored is endotoxin level. The LAL (Lymulus Amebocyte Lysate) test is used to rule out that products given to patients will cause fever. This assay uses a lysate obtained from Limulus Polyphemus blood cell, amebocytes, to detect and quantify endotoxin released by gram-negative bacteria. Limulus Polyphemus amebocytes in presence of bacterial endotoxins activate an enzymatic reaction that leads to a local blood coagulation cascade.

Procelltech uses a Cromogenic LAL test. This assay uses a LAL reagent containing all enzymatic factors needed for reaction to occur in presence of endotoxins and a cromogenic substrate that is released only as a consequence of the reaction. The detection of this assay is made within one hour after mixing the sample and the LAL reagent and is kinetic and quantitative using an enodotoxin titration standard curve.