Mat Test For Pyrogens

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Mat test for pyrogens.

In the current study 16 hsa batches were assayed for pyrogens in parallel with the rabbit pyrogen test conventional and endotoxin specific lal assay and monocyte activation test mat. The pyrogen test is designed to limit the risk of febrile reaction following parentral administration of drugs. The pyrogen test aims to prove that the concentration of pyrogens contained in the product does not exceed a certain threshold known as the contaminant limit concentration clc that will preserve patient safety. Nowadays the most used tests are the rabbit pyrogen test rpt and or the bacterial endotoxin test bet.

In vivo test rabbit test. Mat was pointed to as the compendial method of pyrogen detection in the european pharmacopoeia chapter 2 6 30 and since the 2016 revision recommendations have been given to replace tests on rabbits with the mat wherever possible and after product specific validation ep 2 6 8 rev. In vitro test lal test 2. The monocyte activation test mat can detect both endotoxin and non endotoxin pyrogens in one test.

According to the regulations to ensure quality control of parenteral drugs the suitability of the mat must be demonstrated in a product specific validation. To the rabbit inject intravenously 10 ml of pyrogen free saline solution. Supported by many regulatory bodies the robust mat assay produces sensitive results based on the human immune reaction. At that time the pyrogenic agent was identified as endotoxins included in preparations of gram negative bacteria.

Testing for pyrogens is a critical step in ensuring the safety of parenteral pharmaceutical products and medical devices. The assay is based on the human immune response by measuring cytokine production of human peripheral blood mononuclear cells pbmc. 5 the nonspecific nature of the mat makes it superior to the bet in the assessment of multiple innate immune response modifiers. Agents pyrogens were identified in 1912 by hort and penfold who were also the first to design a pyrogen test based on injection of material into rabbits.

In recent years an alternative in vitro pyrogen test the monocyte activation test mat has been developed to detect and quantify endotoxin and nep contaminations. It includes both in vitro and in vivo tests. 6 the detection of relevant or unusual endotoxin levels in a sample is a sign of danger but presence or absence of endotoxin can t be directly converted into pyrogenicity absence of pyrogenicity. The depth of insertion is constant for any one rabbit in any one test.

It was found that all hsa batches were contaminated with 1 3 beta glucans which interfere with the conventional lal.