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

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

Bernried, Germany

Course No 21194

This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager". Learn more.

Participants of the “Low Endotoxin Recovery Laboratory Training Course” on 05/06 March 2024 in Bernried get a € 200 Discount.


This training/webinar cannot be booked. To find alternative dates for this training/webinar or similar events please see the events list by topic.

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If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail:


Jacqueline Dünisch, Labor LS
Maria Gajewi, Microcoat
Dr Marcus Gutmann, Julius Maximilians University Würzburg
Dr Ruth Röder, Microcoat
Dr Ingo Spreitzer, Paul-Ehrlich-Institut
Dr Sandra Stoppelkamp, University Tübingen and South Westphalia University of Applied Sciences
Delphine Trelat, Sanofi Pasteur


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.


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.
  • Get an alternative Test, where the classic LAL shows some gaps, e.g. Contamination of biologicals by non-endotoxin pyrogens not detectable in 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

This course is addressed to all persons of
  •  pharmaceutical manufacturers
  •  biopharmaceutical companies
  •  medical device manufacturers
  •  contract laboratories
  •  tissue establishments
  •  authorities
who are involved in Endotoxin and Pyrogen Testing in development, IPC or release.

Presentations / Certificate

The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.


Pyrogens – Fever Inducing Agents and the Principle of the Monocyte Activation Test
  • What are pyrogens?
  • Diversity of pyrogens
  • Activation of the human immune system through TLRs stimulation
  • Detection of cytokines using the MAT
MAT - a Compendial Test Method
  • Explanation of European Pharmacopoeia 2.6.30
  • International status of MAT
Hands-on Training in the Laboratory
  • Experimental set-up and preparation of samples (e.g., stimulation of cells)
  • Loading of cells on assay plate
Pyrogen Testing - Fever in an Animal‘s Body
  • History of the Rabbit Pyrogen Test
  • Pharmacopoeial requirements
  • Regulatory requirements and animal welfare (EU-Directive 2010/63/EU)
  • Field of application
  • Future of pyrogene detection
Background and Details on Available Monocyte Activation Tests
  • Vendors of MAT
  • Composition of the different MATs
  • Specifity/Sensitivity
Recap of Day 1

Hands-on Training in the Laboratory
  • Measurement of Samples
Development of the MAT on Vaccines Containing Inherently Pyrogenic Components
  • Intro to Vaccines and Pyrogens – Choice of method
  • MAT development for vaccines containing inherent pyrogen components
  • Case Study 1: Characterization of the absence of NEP
  • Case Study 2 : Consistensy of production in the case of product containing intrinsic pyrogen
Challenges in Applying the Monocyte Activation Test for Routine Testing in the QC Environment
  • Current regulatory perspectives
  • Selection of Monocytes
  • Read-out of Cytokines
  • Methods
Generic Method and Specific Product Validation of the Monocyte Activation Test
  • Development of MAT method
  • Generic method Validation
  • Product-specific validation
  • Release testing
Hands-on Laboratory Results
  • Presentation of the laboratory results
  • Discussion of the results

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