The Monocyte-Activation Test

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MAT enables animal-free detection of broad spectrum of pyrogens


“With the PyroDetect System we have a verified non animal alternative to replace the rabbit pyrogen test following successful product specific validation and are pleased that we can continue to meet the expectations of our clients by offering a high quality in vitro method capable of detecting both endotoxin and non-endotoxin contamination.”

Dr. Joanna Greenhough; R&D Scientist at Wickham Laboratories Ltd

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A Pyrogen Testing Method Recently Introduced into the European Pharmacopoeia

In the past, the rabbit pyrogen test (RPT) and the Limulus Amoebocyte Lysate (LAL) test were the most frequently applied methods in the pharmaceutical, medical devices and cosmetics industries to detect pyrogens. Both methods are limited in the products and range of pyrogens which can be detected. For example, the LAL test can only detect endotoxins. Both also have a high level of animal consumption. To overcome these limitations, the Monocyte- Activation Test (MAT) was introduced into the European Pharmacopoeia (EP) in 2010 (EP chapter 2.6.30).

Using whole human blood (cryoblood or fresh blood), the MAT immitates the innate immune response to a fever reaction caused by pyrogens. It simulates the human fever reaction better than any animal-based pyrogen test.

The MAT provides a high level of reliability due to including both a positive and a negative control. An international validation project coordinated by the European Center for the Validation of Alternative Methods (ECVAM) in 2005 demonstrated the MAT to be highly robust. Several other published studies have shown the robustness and reliability of the MAT’s test performance.

Merck’s PyroDetect System is a Monocyte-Activation Test which uses cryo-preserved human whole blood and generates an interleukin-1ß response when pyrogens are detected. It allows the performance and calculation of the MAT according to the requirements of the European Pharmacopoeia.

Comparison of Pyrogen Test Methods

Rabbit LAL PyroDetect
Test principle Fever reaction in mammal Defence mechanism Fever reaction in human
Contamination Gram-negative (LPS) + + +
Gram-positive (LTA) + - +
Yeasts & Molds + - +
Virus +/-1 - +
Application Pharmaceuticals + + +
Biologicals (e.g. gene therapy, recombinant therapeutic proteins) + +/-2 +
Medical devices  +3 +/-3 +
Cell therapeutics (e.g. monoclonale antibody) - +/- +

(1 Variable pyrogen results, 2 Rabbit test often required,3 Indirect test with solution in pyrogen-free water)
Table 1: Comparison of the Rabbit Test, the LAL test and the PyroDetect System

 
 
Pyrogen Detection White Paper

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Monocyte Activation Test (MAT):
In Vitro Test for Pyrogen
Detection


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Wickham Lab Case Study

Wickham Lab Case Study

Life Cycle of an Analytical Method – Monoctye Activation Test

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Events

Apr 25
25/04/18 - 26/04/18
IAFP European Symposium on Food Safety
The Brewery Conference Centre
Stockholm, Sweden
Industrial Biomonitoring Europe 20180425
May 07
07/05/18 - 10/05/18
TIDES: Oligionucleotide and Peptide Therapeutics
Hynes Convention Center
Boston, MA, USA
Industrial Biomonitoring North America 20180507
Jul 08
08/07/18 - 11/07/18
2018 IAFP Annual Meeting
Salt Palace Convention Center
Salt Lake City, UT, USA
Water Purification,Life Science Research,Industrial Biomonitoring North America 20180708