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?

Endotoxins from Gram-negative bacteria

Endotoxins from Gram-negative bacteria

  • Endotoxins from Gram-negative bacteria
  • Non-Endotoxin Pyrogens (NEPs) from gram-positive bacteria, yeast & mold, virus...
    Activation of monocytes and release of cytokines
      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

        No More Animal-based Pyrogen Tests

        Fill in the form below to discuss with our experts and to start the move to meet regulations and save rabbits!

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