Determination of vaccine bacterial endotoxins content by the rFC method

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. The rFC method has been implemented at Sciensano for batch release of vaccines since March 2023.