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Monocyte Activation Test (MAT) - Hands-on Laboratory Training Course

: 13 Feb 2020 - 14 Feb 2020

: Bernried, Germany

Sector: Pharmaceutical

Type: Training


Objectives

 

This unique event will provide an opportunity for delegates to gain practical experience in performing the Monocyte Activation Test. Further, it brings together industry and regulatory representatives to discuss their practical experiences in using MAT, the advantages, the pitfalls, the available systems as well as the regulatory experiences. The purpose is to provide participants with guidance and support and hands-on laboratory training for the implementation and use of the MAT.

 

Background

 

During recent years manifold advances have taken place to replace both, Rabbit Pyrogen Test (RPT) and in some cases, the Limulus Amebocyte Lysate Test (LAL).

Some of the reasons are:
  • Animal experiments have to be reduced, especially with the current EU Regulations.
  • There needs to be a reduction in variance by validatable in-vitro test methods
  • There is a need to get an alternative test, where the classic LAL shows some gaps
True In-vitro Pyrogen Tests (IVPT) have been developed in several European countries (United Kingdom, The Netherlands, Switzerland, Germany) in national and international research projects. The tests imitate the central step of human fever reaction, i.e., the activation of human monocytes by endotoxin as well as non-endotoxin pyrogens. One result of all these activities is the Monocyte Activation Test (MAT).

Following continuous support from the German Pharmacopeia, the EDQM MAT Expert group was re-established and, finally, the MAT Monograph 2.6.30. was implemented into the European Pharmacopeia in 2010. Meanwhile, the EDQM performed a MAT-survey to improve the MAT monograph and the BET-Guideline 5.1.10. and the Rabbit Pyrogen Test (RPT) monograph, 2.6.8. was revised. However, there remain questions about how the MAT can be applied in a routine lab for release testing. This meeting will give guidance for proper use of the MAT, and its strengths and weaknesses will be discussed.
Venue

Bernried
Germany


Organizer

ECA Academy
Phone: +49 (0)6221 84 44 0
Email: info@gmp-compliance.org
Visit: https://www.gmp-compliance.org/training


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