Dr. Marcus Gutmann
Julius-Maximilian Universität Würzburg
Referent:innen
Dr. Ingo Spreitzer
Paul-Ehrlich-Institut
Jacqueline Dünisch
Labor LS
Dr. Sandra Stoppelkamp
Universitäts-Klinikum Tübingen
Delphine Trelat
Sanofi Pasteur
Dr. Ruth Röder
MicroCoat
Participants of the “Low Endotoxin Recovery Laboratory Training Course” on 18/19 March 2025 in Bernried get a € 200 Discount.
Zielsetzung
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.
Hintergrund
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:
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.
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.
Zielgruppe
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.
Date / Venue / Presentations / Certificate
Thursday, 20 March 2025, 09.00 – 17.15 h
(Registration and coffee 08.30 – 09.00 h)
Friday, 21 March 2025, 08.45 – 16.15 h
Overnight Stay
Hotel Seeblick
Tutzinger Straße 9
82347 Bernried am Starnberger See, Germany
Phone +49 (0) 8158 / 254 – 0
Email info@seeblick-bernried.de
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 19 March at appr. 19.00 h from Munich Airport to Hotel Seeblick.
On 21 March at appr. 16.30 h from Microcoat to Munich Airport.
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.
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
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
| ECA-Member*: | € 1990,- |
| Non ECA Member*: | € 2190,- |
| EU/GMP Inspectorates*: | € 1095,- |
| APIC Member Discount*: | € 2090,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager"
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E-Mail: info@concept-heidelberg.de
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Seminarprogramm als PDF
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