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
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