In Vitro Pyrogen Test using Human Cryopreserved Whole Blood/IL-1 Beta

Topic: Pyrogenicity

Test Method Number:

TM2002-02 (EU)

Short Name of TM:

Cryo-WBT-IL1

Year received:

2002

Responsible Organisation:

EURL ECVAM - European Union

Protocol(s)/SOP(s):

134

General Comments:

Method Description

The In Vitro Pyrogen Test using Human Cryopreserved Whole Blood/IL-1 Beta Cryo-WBT-IL1) is a monocyte activation test (MAT) used to detect or quantify substances that activate human monocytes or monocytic cells 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

Submission
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards

Submission

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Date	Stage	Comment	Documents/Links
Jan 2004	Not applicable

Validation

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Date	Stage	Comment	Documents/Links
Jan 2004	Finalised	The results of the validation study are reported in Schindler et al. International Validation of Pyrogen Tests Based on Cyropreserved Human 10.1016/j.jim.2006.07.023 Primary Blood Cells. Journal of Immunological Methods 2006, 316: 42-51. DOI:10.1016/j.jim.2006.07.023

Peer-review

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Date	Stage	Comment	Documents/Links
May 2005	Ongoing	The ESAC peer-reviewed five in vitro pyrogenicity tests (also named monocyte activation test, MAT) during 2005-2006 including the In Vitro Pyrogen Test using Human Cryopreserved Whole Blood/IL-1 Beta.
May 2006	Finalised	The ESAC statement confirms the scientific validity of five in vitro pyrogenicity tests, including the In Vitro Pyrogen Test using Human Cryopreserved Whole Blood/IL-1 Beta, subject to product specific validation.	ESAC statement

Recommendation

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Date	Stage	Comment	Documents/Links
Mar 2009	Not applicable

Regulatory acceptance/Standards

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Date	Stage	Comment	Documents/Links
Mar 2009	Adopted/published	The European Pharmacopoeia General Method 2.6.30 Monocyte-activation test was adopted by the European Pharmacopoeia Commission in March 2009 and came into force in September 2009. The In Vitro Pyrogen Test using Human Cryopreserved Whole Blood/IL-1 Beta is covered by this text. The MAT is suitable, after product-specific validation, as a replacement for the rabbit pyrogen test and bacterial endotoxin test.