Testing For Endotoxin In Cell Therapy Products

Cell therapy products play a crucial role in addressing medical needs, but they are susceptible to contamination, particularly by endotoxins released by gram-negative bacteria. These endotoxins can cause severe health complications if they enter the bloodstream. To ensure the safety of cell therapy products, endotoxin testing should be conducted at various stages of the manufacturing process. The Limulus amebocyte lysate (LAL) assay is considered the gold standard for determining endotoxin levels. This assay has different variations, including gel-clot, turbidimetric, and chromogenic assays, which offer flexibility in terms of sensitivity and specificity. In addition to the traditional LAL assay, recombinant endotoxin assays have been developed as an environmentally friendly alternative.