The Emerging View of Endotoxin as an IIRMI.

The recognition that microbial artifacts are capable of modulating the mammalian immune system is an emerging view of biologic drug contamination control testing. The term IIRMI, or "innate immune response modulating impurity," has been coined. It is important to recognize that pyrogenicity is only one potential risk of endotoxin contamination and that immune activation is an inherent property of endotoxin, even in the absence of pyrogenicity. Immune stimulation of biologics is undesirable, as it can stimulate anti-drug antibodies against administered recombinant proteins. Historically, many methods have been used to "detoxify" endotoxin to remove the pyrogenicity of endotoxin while retaining its immune stimulation properties for adjuvant use in vaccines. This article gives a broad perspective for understanding potential risks from low endotoxin recovery (LER) and other potential detoxification methods and presents a new paradigm to help drive future testing. [ABSTRACT FROM AUTHOR]

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