Regulations are now evolving to support in vitro methods.
Now is the time, to stop animal-based tests for Pyrogen Detection
The end of the Rabbit Pyrogen Test (RPT) era in the European Pharmacopoeia (Ph. Eur.) will take effect on 1 July 2025. This represents a significant advancement for animal welfare, as no text in the European Pharmacopoeia will require the use of the RPT. Instead, medicine developers must choose an appropriate in vitro method (e.g., the monocyte activation test) based on a risk assessment outlined in the new general chapter. The Monocyte Activation Test (MAT) will be the method of choice in the European Pharmacopoeia for the detection of endotoxins and non-endotoxins.
Used to detect a broad range of pyrogens in medical products administered parenterally, such as pharmaceuticals or biopharmaceuticals, the Monocyte Activation Test (MAT) provides an in vitro alternative to historical rabbit pyrogen test in accordance with regulatory guidelines.
With our Mono-Mac-6 cell-line based MAT, we provide a robust, reliable and standardized method for in vitro endotoxin and non-endotoxin pyrogen detection.
Our PyroMAT® System Combines the Advantages of the MAT With the Benefits of Using a Continuous 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
The MAT kit is based on the Mono-Mac-6 (MM6) cell line and uses interleukin-6 (IL-6) as a read out.
Once these human monocytes come into contact with pyrogens from a contaminated sample, they produce cytokines such as interleukin-6 (IL-6), which can be quantified with an enzyme-linked immunosorbent assay (ELISA).
Why is it important to detect endotoxin and non-endotoxin pyrogens?
Endotoxins, primarily lipopolysaccharides from gram-negative bacteria, are the most common cause of pyrogenic reactions.
However, non-endotoxin pyrogens, which have different structures, can also induce similar harmful effects. Standard tests for bacterial endotoxins may not detect non-endotoxin pyrogens, making it essential to employ comprehensive testing methods, such as the Monocyte Activation Test (MAT), which can identify both types of pyrogens.
Ensuring the detection of all pyrogenic substances is vital for maintaining the safety and efficacy of medicinal products and protecting public health.
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
- Software data analysis for routine testing
Validation Services
- Data analysis for product specific validation (PSV)
Training Services
- Remote training, on-demand and on-schedule
- Interactive e-learning
- Pyrogen testing school
Related Product Resources
- Brochure: PyroMAT® and PyroDetect
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.
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