Ideal properties of a LAL reagent for pharmaceutical testing

Evaluation of medical devices and pharmaceutical products for endotoxin content is the most significant biomedical application of Limulus amebocyte lysate (LAL). This review summarizes the means by which LAL reagent suppliers have introduced different production techniques and formulation additives to uniquely optimize their products for industry. Pharmaceutical testing requires a LAL reagent that is buffered, stabilized to a sensitivity of 0.12 EU/ml, optimized to detect E. coli-derived LPS in water, formulated to produce firm opaque gels, designed specifically to detect bacterial endotoxin, and is economical. Unique LAL reagent characteristics produce nonuniformity in drug compatibility testing but does not significantly alter detection of unsafe levels of native endotoxin. Design of a clinical LAL reagent may require additional means for standardization and exclusion of additives which are only useful for pharmaceutical testing. A cooperative effort between clinical investigators and the LAL industry should resolve these issues in a reasonable period of time.