As pyrogen testing in rabbits (Ph. Eur. 2.6.8) is from now on only allowed in exceptional cases by the European legislation bodies, appropriate alternative methods shall be used for pyrogen testing. Alternatives given in the European pharmacopeia are the monocyte activation test (MAT, PH. Eur. 2.6.30) and the bacterial endotoxin test (BET, Ph. Eur. 2.6.14; Ph. Eur. 5.1.10). Whereas the BET is only detecting LPS of gram-negative bacteria, the MAT has the advantage of detecting a broad range of pyrogens. Thus, the MAT gives a higher safety in pyrogen testing and is more comparable to the in-vivotesting in rabbits.
In this context MicroMol is happy to offer the monocyte activation test for medical devices and pharmaceuticals (ISO 17025 accredited and GMP compliant) to our customers. The MAT is fully established and verified according to Ph. Eur. 2.6.30. Our long standing experience and high expertise in immunological and cell biology based techniques allowed us to establish our own, in house-method based on human blood pools with IL-6 as the standard readout. Readout levels on a customized, multiplexing workflows i.e. using IL-6, IL-1beta, and TNF-α as readout can also be established upon request. MicroMol’s service include testing of your medical devices or pharmaceuticals from feasibility studies, to product specific verification, and routine analysis.
As a member of the Tentamus Group, MicroMol offers the full range of endotoxin and pyrogen testing: GMP-compliant, ISO 17025 accredited!
In this context MicroMol is happy to offer the monocyte activation test for medical devices and pharmaceuticals (ISO 17025 accredited and GMP compliant) to our customers. The MAT is fully established and verified according to Ph. Eur. 2.6.30. Our long standing experience and high expertise in immunological and cell biology based techniques allowed us to establish our own, in house-method based on human blood pools with IL-6 as the standard readout. Readout levels on a customized, multiplexing workflows i.e. using IL-6, IL-1beta, and TNF-α as readout can also be established upon request. MicroMol’s service include testing of your medical devices or pharmaceuticals from feasibility studies, to product specific verification, and routine analysis.
As a member of the Tentamus Group, MicroMol offers the full range of endotoxin and pyrogen testing: GMP-compliant, ISO 17025 accredited!
