Monocyte Activation Test (MAT) - Hands-on Laboratory Training Course
Bernried, Germany
Course No 17425
Our Service
Costs
| Non ECA Member: | EUR 1990,-- |
| ECA-Member: | EUR 1790,-- |
| EU/GMP Inspectorates: | EUR 995,-- |
| APIC Member Discount: | EUR 1890,-- |
(All prices excl. VAT)
If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
Speakers
Esther Frey, Novartis Pharma
Dr Anja Fritsch, Confarma
Stefan Gärtner, Labor LS
Koen Marijt, MAT Research
Dr Ilka Molitor, Novartis Pharma
Ruth Röder, Microcoat
Shabnam Solati, CTL-MAT
Dr Ingo Spreitzer, Paul-Ehrlich-Institut
Dr Sandra Stoppelkamp, Universität Tübingen and South Westphalia University of Applied Sciences
Dr Anja Fritsch, Confarma
Stefan Gärtner, Labor LS
Koen Marijt, MAT Research
Dr Ilka Molitor, Novartis Pharma
Ruth Röder, Microcoat
Shabnam Solati, CTL-MAT
Dr Ingo Spreitzer, Paul-Ehrlich-Institut
Dr Sandra Stoppelkamp, Universität Tübingen and South Westphalia University of Applied Sciences
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:
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 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. 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 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 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. 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 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.
Programme
Pyrogens – Fever inducing agents and the principal 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
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
Pyrogen testing from a Pharma QC perspective
- The Rabbit Pyrogen Test – Pros and Cons for the pharmaceutical industry
- The Monocyte Activation Test – challenges and opportunities
Monocyte Activation Test: The In-vitro Pyrogen Test Based on Human Immune Cells for Batch Release Testing of Medical Products
- Presenting the MAT as a robust, reproducible, sensitive and human specific pyrogen testing
- An end-to-end process: MAT kit generation, test performance and product-specific validation
- Presenting the solution to the recent EP criteria: MAT as risk assessment for the endotoxin test and replacement of RPT
- The solution for pyrogenicity tests of medical devices
Hands-on training in the Lab
Preparation of Samples (e.g. stimulation of cells)
Preparation of Samples (e.g. stimulation of cells)
- Multiple read-out of cytokines
- Available multiple read-out platforms
- Case study: Comparison of platforms
Measurement of Samples
Case study – Cryo blood and Cell-based MAT
Case study – Cryo blood and Cell-based MAT
- Performance of cryo blood and cell-based MAT
- Pros and Cons of particular Systems
Case study – PBMC based MAT
- Performance of PBMC-based MAT Pros and Cons of particular systems
MAT on medical devices – suitable alternative test method for pyrogen- and material-induced activation?
- How the new ISO 10993-11 guideline affects the testing
- Diversity of the test results with MAT variants
- Possible interpretation of the MAT variant outcomes
MAT and its challenges
- Variability of test systems
- Interpretation of test results
Presentation and discussion of results
GMP Conferences by Topics
- Quality Assurance
- GMP in Biotechnology
- Microbiology
- Regulatory Affairs
- GMP in Pharmaceutical Development
- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
- Computer Validation
- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity