Whitepaper: Beta-glucans in purified water – do they really cause overestimation of endotoxin values?
Over the last century, the bacterial endotoxin test (BET) has evolved to keep pace with modern technology and lab expectations: from rabbit pyrogen testing to Limulus amebocyte lysate (LAL), to current developments with recombinant horseshoe crab coagulation factors.
The advancement of process and product testing methodology has been historically important as they benefit patient safety and can result in sustainable and non-inferior testing capacity. There are currently three commercially available recombinant Factor C (rFC) reagents and a fully recombinant LAL (rLAL) in development by Charles River. Global compendia’s current position is that recombinant LAL requires validation as an alternative method.