Endotoxin testing is a quality control assay used to detect and quantify bacterial endotoxins, which are toxic components of the outer membrane of Gram-negative bacteria. These endotoxins, primarily lipopolysaccharides (LPS), can cause severe immune reactions if present in pharmaceutical products, especially injectable biologics. Endotoxin testing is a critical requirement in GMP manufacturing to ensure product safety, and it is applied throughout biopharmaceutical production, including raw materials, in-process samples, and final drug products.
