Validation of an animal-free analytical method for the detection of bacterial endotoxins in human vaccines

Sciensano, as official medicines control laboratory (OMCL) following “Official Control Authority Batch Release” (OCABR) guidelines, is entitled to check the concentration of endotoxin in bacterial vaccines. The limulus amebocyte lysate (LAL) and the recombinant factor C (rFC) assays are suitable for all vaccines tested, although the most appropriate technique of endotoxins quantification depends on the type of vaccine.