Regulations are now evolving to support in vitro methods.
Now is the time, to stop animals-based
tests for Pyrogen Detection
In June 2021, the European Pharmacopoeia (Ph. Eur.) Commission made the decision to engage on a path that should ultimately lead to the complete replacement of the rabbit pyrogen test (RPT) in the Ph. Eur., within approximately 5 years. In the meantime, users are actively encouraged to seek alternatives to chapter 2.6.8, the best option being the Monocyte Activation Test (MAT).
Used to detect a broad range of pyrogens in parenteral products such as pharmaceuticals, biopharmaceuticals or medical devices, the MAT gives an in vitro alternative to conventional animal testing in accordance with regulatory guidelines.
With our Mono-Mac-6 cell-line based MAT, we provide a robust, reliable and standardized method for pyrogen detection.
Our PyroMAT® System Combines the Advantages of the MAT With the Benefits of Using a Cell Line
- Detection of a broad range of pyrogens
- Testing of a wide range of product types
- In vitro assay that mimics the human immune reaction
- Compliance with regulations and guidelines
- Standardized reactivity and high sensitivity (LOD 0.05 EU/mL)
- Qualified cells: based on the Mono-Mac-6 (MM6) cell line
How does the PyroMAT® system work?
Activation of monocytes and release of cytokines (IL-1β, IL-6, TNF-α, IFN-γ…)
Detection of IL-6 with ELISA test
We Will Help You to Shift from Animal-based Testing to in Vitro Testing
For our PyroMAT® system, we have a broad offer of Services and Trainings to support the implementation of the monocyte activation test (MAT) in your lab:
Application Services
- Feasibility study
- Method development
- Method development consultancy at your site or remotely
- Implementation troubleshooting
- Software data analysis for routine testing
Validation Services
- Product specific validation consulting at your site or remotely including PyroMAT® system training and demo
- Data analysis for product specific validation (PSV)
Training Services
- Remote training, on-demand and on-schedule
- Interactive e-learning
- Advanced operator training at your site
- Pyrogen testing school
Related Product Resources
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