Endotoxin as an IIRMI

Kevin Williams has written a key article for BioPharm International, titled “The Emerging View of Endotoxin as an IIRMI.” This concerns the recognition that microbial artifacts are capable of modulating the mammalian immune system is an emerging view of biologic drug contamination control testing.

Here is an extract:

“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.”

For details see: BioPharm



 Posted by Dr. Tim Sandle