The impact of supply chain risks and LAL reliance
For over 30 years, pharmaceutical and medical device product release has relied solely on endotoxin assays using Limulus Amebocyte Lysate (LAL). This article addresses the potential risks associated with relying on a single raw material in a fragile supply chain and explores alternative testing options.
THE RELIANCE on a vulnerable or endangered animal to produce a unique reagent for endotoxin testing of drugs, vaccines and medical devices should be examined as a wake-up call for investigating and finding alternate ways to counter our dependence on this fragile segment of the overall supply chain. For over 30 years, pharmaceutical and medical device product release has relied solely on endotoxin assays using Limulus Amebocyte Lysate (LAL), as a replacement for the rabbit pyrogen test, to ensure that those products are free of harmful endotoxin. LAL is derived from only one source: the blue blood of the horseshoe crab. No other natural source exists, making this one of the rare and unique instances of a precious test ingredient being totally dependent on the continued existence and abundant supply of a single animal.