Recombinant (Synthetic) LAL vs. Traditional LAL Assay

The article discusses the difference between traditional Limulus amebocyte lysate (LAL) assays and recombinant LAL assays for endotoxin testing. Bacterial endotoxins can be harmful if they enter the bloodstream, so endotoxin testing is crucial in the manufacturing process of pharmaceutical drugs and medical devices. The traditional LAL assay, which can be performed qualitatively or quantitatively, requires the capture and bleeding of horseshoe crabs to produce the LAL reagent. This has an environmental impact. Recombinant alternatives, such as recombinant factor C-based assays and the Pyrostar synthetic LAL assay, have been developed. These synthetic assays offer high sensitivity and specificity without the need for horseshoe crab amebocytes. The development of these recombinant tests reduces the environmental impact and aligns with the goal of replacing, reducing, and refining the use of animals in scientific research.