Pyrogen Testing

 

Testing for pyrogens is a critical step in ensuring parenteral pharmaceutical product and medical device safety. It is part of the mandatory release tests to avoid life-threatening fever reactions induced by pyrogenic substances. The monocyte activation test (MAT) can detect both endotoxin and non-endotoxin pyrogens in one in vitro test.

MONOCYTE ACTIVATION TEST (MAT)
Used to detect both endotoxins and non-endotoxin pyrogens in parenteral products, such as pharmaceuticals and medical devices, the MAT gives an in vitro alternative to conventional animal testing in accordance with regulatory guidelines.

The Rabbit Pyrogen Test and the Limulus Amebocyte Lysate (LAL) test are broadly used for pyrogen detection. Both methods use animals and show some limitations. The rabbit pyrogen test shows a lack of robustness as an animal reaction can differ greatly from a human reaction. In the LAL test, only endotoxins are detected causing a safety risk by ignoring non-endotoxin pyrogens that could be present in the tested sample.

To overcome these limitations, the Monocyte-Activation Test (MAT) was introduced in the European Pharmacopoeia in 2010 as a compendial method to replace the Rabbit Pyrogen Test (EP Chapter 2.6.30) and mentioned in FDA guidance for industry.

Please Note: The European Pharmacopoeia Commission took the decision to put an end to the rabbit pyrogen test in accordance with the 3Rs principle considering that the MAT is the best alternative option.
Read the article and discuss further with our Experts to start the move.

PyroMAT® IN VITRO TEST TO DETECT ENDOTOXIN AND NON-ENDOTOXIN PYROGENS
The PyroMAT® system is based on the Mono-Mac-6 cell line and IL-6 read-out. It offers all the advantages of the monocyte activation test combined with the benefits of using a cell line.

  • Detection of a broad range of pyrogens: patient safety is ensured if the full range of pyrogens are tested. Like the rabbit pyrogen test (RPT), MAT is effective for both endotoxin and non-endotoxin pyrogen detection.
  • Extension of the range of products that can be tested: the most frequently applied methods, RPT, Bacterial Endotoxin Test (BET) or LAL, are limited in the product types they are able to test. The MAT offers more flexibility regarding its applications.
  • In vitro assay that mimics the human immune reaction: for a robust predictive model that reduces animal consumption.
  • Compliance with international regulations and guidelines: in line with ethical trends of industry and regulatory authorities to decrease the use of animal-based testing.
  • Standardized reactivity and high sensitivity (LOD 0.05 EU/mL). Convenience of a ready-to-use cell line reduces laborious lab work and avoids the need for a cell culture laboratory.
  • Qualified cells: in addition to being cited in the international validation of MAT, Mono-Mac-6 cells are qualified for the expression of all surface Toll-Like Receptors (TLRs) to ensure the detection of a broad range of pyrogens.
     
    To read more about Non-endotoxin Pyrogen Postive Controls click here

Products

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  • Product Name
Set Descending Direction
Product Number Product Description Pricing
Z637203 *DEL*MUCASOL(TM) UNIVERSA L DET Expand
Z375357 BRIGHT-LINE(TM) HEMACYTOM Expand
D1685 DOCUSATE SODIUM USP OCUSATE SODIUM USP Expand
E0774 Erythromycin, meets USP t Expand
PYR0MATIL6 Interleukin IL-6 standard for control reactions in Expand
MATHKSA Non Endotoxin Pyrogen control of Heat Killed Expand
MATFLAGELLIN Non Endotoxin Pyrogen of flagellin, TLR-5 agonist Expand
1.44155 Pyrodetect Cryoblood Expand
1.44161 PyroDetect Endotoxin Standard Expand
1.44158 PyroDetect Interleukin Standard Expand
1.44154 PyroDetect Kit Expand
W296708 PYROLIGNEOUS ACID, NATURA Expand
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