Recombinant bacterial endotoxin testing techniques shown to be inferior

An evaluation comparing Limulus amebocyte lysate to recombinant alternative assays has found that the recombinant reagents had markedly low recovery of endotoxin activity.

Recently there has been scrutiny of the United States Pharmacopeia (USP), European Pharmacopeia (Ph. Eur.) and Parenteral Drug Association (PDA) guidance discussing alternative microbiological methods. The alternative, recombinant Factor C (rFC) methods for BET have been particularly controversial. Read more!