European Pharmacopoeia Commission adopts revised general chapter on monocyte activation test to facilitate reduction in animal testing

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European Pharmacopoeia Commission adopts revised general chapter on monocyte activation test to facilitate reduction in animal testing

Sherry Ward, AltTox

Source: https://www.edqm.eu/en/node/15240

“During its 155th Session, held in Strasbourg on 21-22 June 2016, the European Pharmacopoeia Commission adopted a revision of the general chapter Monocyte-activation test (2.6.30) in order to make it more widely useable by stakeholders and thus facilitate a reduction in testing on live animals.”

The press release provides additional information, including the following summary about the monocyte activation test:

“The monocyte activation test (MAT) is used to detect or quantify substances that activate human monocytes or monocytic cells to release endogenous mediators which have a role in the human fever response. The MAT is suitable, after product-specific validation, as a replacement for the rabbit pyrogen test (RPT).

The MAT offers significant advantages over animal testing: based on the human fever response, it provides a more relevant prediction of pyrogenic activity than the RPT, it can detect endotoxin and non-endotoxin pyrogens and is applicable to a greater variety of products than the RPT; moreover, it is more accurate as well as more cost- and time-effective than the RPT.”

 

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