Topic: Pyrogenicity
Test Method Number:
TM2002-03 (EU)
Short Name of TM:
MM6 IL6
Year received:
2002
Responsible Organisation:
General Comments:
Method Description
The In Vitro Pyrogen Test using MonoMac 6 cells/IL-6 (MM6-IL6) is a monocyte activation test (MAT) applied to detect or quantify substances that activate human monocytes or monocytic cells (here the cell line MonoMac 6) to release pro-inflammatory cytokines, for example tumour necrosis factor alpha (TNFα), interleukin-1 beta (IL-1β) and interleukin-6 (IL-6).
These cytokines have a role in fever pathogenesis. Consequently, the MAT can detect the presence of pyrogens in the test sample. The MAT is suitable, after a product-specific validation, as a replacement for the rabbit pyrogen test or the bacterial endotoxin test (Limulus amebocyte lysate assay).
Track Approval Status
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Submission
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Validation
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Peer-review
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Recommendation
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Regulatory acceptance/Standards
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