Objectives

This unique event is organised to gain practical experience in performing the Monocyte Activation Test. Further, it brings together industry and regulatory representatives in order to discuss the practical experiences in using MAT, the advantages, the pitfalls, the available systems as well as the regulatory experiences. The purpose is to provide the 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.
• Reduction of variance by validatable in-vitro test Methods.
• Getting an alternative test where the classic LAL shows some gaps, e.g., Contamination of biologicals by non-endotoxin pyrogens not detectable in the LAL test, is not unlikely.

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, with continuous support by the German Pharmacopoeia, the EDQM MAT Expert group was re-established and finally the MAT Monograph 2.6.30. was implemented into the European Pharmacopoeia 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. have been revised to clarify the priorisation of the MAT compared to the RPT (especially in regards to the EU directive 2010/63). However, there are still open questions how MAT can be applied in a routine lab for release testing. The meeting will give guidance for proper use of MAT and strengths and weaknesses will be discussed.

Target Group

• pharmaceutical manufacturers
• biopharmaceutical companies
• medical device manufacturers
• contract laboratories
• tissue establishments
• authorities

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