White Paper: Non-endotoxin Pyrogens Jeopardize Life-saving Drugs and Clinical Trials

Popular endotoxin detection kits based on the horseshoe crab blood cell lysates fail to address the detrimental impact of non-endotoxin pyrogens or fever-causing substances on the effects of parenteral medical drugs in their different phases of clinical applications. However, new detection methods can identify all pyrogenic contaminants in injectable medicines and implantable medical devices, and help reduce or eliminate the risk of fever, septic shock, organ failure or death associated with the administration of new drugs or compounds.

Despite the reassuring negative results provided by endotoxin, Mycoplasma and sterility tests, current gene and cell therapies have shown adverse events or side effects of variable severity, particularly in cancer patients. Clinical trials may have been compromised, in some cases stopped, due to unsuspected non-endotoxin pyrogens. It is possible that investigational drugs of high pharmacological quality have been abandoned for this reason after several years of investment, a significant blow to startups or established organizations as well as patients. As interest in immunotherapy for the treatment of cancers and other diseases increases, this class of non-endotoxin pyrogens remains a major problem that the current commercially available LAL and Mycoplasma kits do not address...

Learn more about the liabilities of popular endotoxin detection tests, and the benefits of MAT testing.

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Djik Maouyo