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)
- 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
- 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