Alternative method for Pyrogen Testing
MicroMol announces the implementation of the monocyte activation test (MAT Ph. Eur. 2.6.30)
(PresseBox) - 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-? 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!
Tentamus Group GmbH was founded in 2011. Tentamus is a global product and safety group with a core presence in Europe, UK, Israel, China, Japan and the USA. Accredited and licensed Tentamus Group tests, audits and consults on all products involving the human body (food & feed, pharmaceuticals & medical, agrochemicals, cosmetics, agriculture & environment and nutraceutical & supplements). Tentamus Group is represented in over 52 locations worldwide. More than 2,500 highly-trained staff members work in over 2.5 million square feet of laboratory and office spaces. For further information please visit www.tentamus.com.
Tentamus Group
An der Industriebahn 5
13088 Berlin, Germany
www.tentamus.com
Unternehmensinformation / Kurzprofil:
Tentamus Group GmbH was founded in 2011. Tentamus is a global product and safety group with a core presence in Europe, UK, Israel, China, Japan and the USA. Accredited and licensed Tentamus Group tests, audits and consults on all products involving the human body (food&feed, pharmaceuticals&medical, agrochemicals, cosmetics, agriculture&environment and nutraceutical&supplements). Tentamus Group is represented in over 52 locations worldwide. More than 2,500 highly-trained staff members work in over 2.5 million square feet of laboratory and office spaces. For further information please visit www.tentamus.com.Tentamus GroupAn der Industriebahn 513088 Berlin, Germanywww.tentamus.com
Datum: 15.04.2019 - 08:22 Uhr
Sprache: Deutsch
News-ID 591129
Anzahl Zeichen: 2425
contact information:
Town:
Berlin
Kategorie:
Energy & Utilities
Diese Pressemitteilung wurde bisher 211 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Alternative method for Pyrogen Testing"
steht unter der journalistisch-redaktionellen Verantwortung von
Tentamus Group GmbH (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
