Monocyte Activation Test (MAT) - Hands-on Laboratory Training Course
12/13 March 2026, Bernried, Germany
Course No. 22500
Speakers
Dr. Ingo Spreitzer
Paul-Ehrlich-Institut
Dr. Sandra Stoppelkamp
Universitäts-Klinikum Tübingen
Dr. Ruth Röder
MicroCoat
Participants of the “Low Endotoxin Recovery Laboratory Training Course” on 10/11 March 2026 in Bernried get a € 200 Discount.
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.
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.
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.
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.
Programme
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
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
Further Information
Overnight Stay Hotel Seeblick Tutzinger Straße 9 82347 Bernried am Starnberger See, Germany Phone +49 (0) 8158 / 254 – 0 Email info@seeblick-bernried.de
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the Hotel Seeblick. You will receive a room reservation form/POG when you have registered for the conference. Reservation should be made directly with the hotel. Early reservation is recommended.
Venue of the Laboratory Course Microcoat Biotechnologie GmbH Am Neuland 3 82347 Bernried am Starnberger See, Germany Transfer service from Hotel Seeblick to Microcoat in the morning and back in the evening will be organised. Shuttle Service from/to Munich Airport: On 11 March at appr. 19.00 h from Munich Airport to Hotel Seeblick. On 13 March at appr. 16.30 h from Microcoat to Munich Airport.
Fees (per delegate, plus VAT) ECA Members € 1,990 APIC Members € 2,090 Non-ECA Members € 2,190 EU GMP Inspectorates € 1,095 The fee is payable in advance after receipt of invoice and includes laboratory materials, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Social Event On the evening of the first course day, the participants are cordially invited to a dinner. This event is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
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.
Conference language The official conference language will be English.
Contacts Questions regarding content: Mr Axel H. Schroeder (Operations Director), +49(0)62 21 84 44 10, schroeder@concept-heidelberg.de. Questions regarding organisation: Ms Isabell Helm (Organisation Manager), +49(0)62 21 84 44 49, helm@concept-heidelberg.de.
Date & Time
Thursday, 12 March 2026, 9:00 – 17:15 h (Registration/coffee 8.30 – 9:00 h) Friday, 13 March 2026, 8:45 – 16:15 h
Testimonials
