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PyroCell® Monocyte Activation Test Rapid System

PyroCell® Monocyte Activation Test Rapid System

Catalog #: 00296407

The PyroCell® Monocyte Activation Test – Fetal Bovine Serum (FBS) Rapid System is an all-inclusive kit to conduct the Monocyte Activation Test. It contains 3 vials of cryopreserved, pooled PBMC (human, pMAT Cells), 3 vials MAT Culture Medium Supplement, and the NEW PeliKine human IL-6 ELISA Rapid Kit, for 288 test (3x 96-well ELISA plates).

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Product Overview

The Monocyte Activation Test (MAT) is an in vitro assay for pyrogen testing in pharmaceutical and medical device industries. The Monocyte Activation Test principle is based on the detection of pro-inflammatory cytokines released by human monocytes in response to exogenous endotoxins (LPS) and non-endotoxin pyrogens (NEP). 

The Monocyte Activation Test has been adopted by the European Pharmacopeia in 2010 (Ph. Eur. chapter 2.6.30) Today, the Monocyte Activation Test is MAT recognized as a compendial method for pyrogen testing in several world regions including Europe. Here, the Monocyte Activation Test will be fully replacing the Rabbit Pyrogen Test (RPT) as of 2026 (1). The Monocyte Activation Test is further compliant to the EU Directive 2010/63/EU on the protection of experimental animals and the global framework of the 3Rs (replacement, refinement, reduction of experimental animal tests). (2) 

Each PyroCell® Monocyte Activation Test is performed in two steps: during an overnight cell culture step, the monocytic cell preparation consisting of pooled peripheral blood mononuclear cells (PBMC, pMAT) is stimulated for release of inflammatory cytokines with a product preparation that may contain a pyrogenic contaminant. On the next day, the cell culture supernatant is analyzed for the presence of IL-6 cytokines using the Pelikine Human IL-6 Rapid ELISA assay. The color reaction is measured using a multimode reader, e.g the Nebula® Absorbance Reader or the Nebula® Multimode Reader at a wavelength of 450nm and a reference wavelength of 540-590nm or alternatively, an absorbance reader, e.g. the ELx808TM Reader, at the same wavelength. The pyrogenic content of the sample is then analyzed against the reference standard endotoxin (RSE) and is expressed in Endotoxin Equivalent Units (EEU/mL). 

The PyroCell® Monocyte Activation Test Rapid System (PyroCell® MAT Rapid System) is an all-inclusive kit containing all necessary reagents for the Monocyte Activation Test: the PyroCell® Monocyte Activation Test Kit (PyroCell® MAT Kit)  that contains the cryopreserved, human PBMC preparation pooled from 4 healthy human blood donations (pMAT Cells) along with an optimized MAT Culture Medium Supplement, and the Pelikine Human IL-6 ELISA Rapid Kit. that contains all reagents and buffer concentrates to conduct the human IL-6 ELISA.  

pMAT Cells are specifically qualified for pyrogen detection with the Monocyte Activation Test, e.g. are certified for their ability to detect endotoxin and non-endotoxin pyrogens. Thereby, donor selection, cell preparation and quality testing strictly follow the compendial requirements outlined in the Ph. Eur. Chapter 2.6.30. The MAT Culture Medium supplement is formulated with special attention to low endotoxin content in order to ensure error-free cell stimulation conditions. The PyroCell® MAT Rapid Kit has been validated for use with the PeliKine Human IL-6 ELISA Rapid Kit for sensitive detection of the released pro-inflammatory cytokine interleukin 6 (IL-6).

The new Pelikine Human IL-6 ELISA Rapid Kit is composed of an ELISA detection kit and buffer concentrates ensuring rapid and highly sensitive detection of the human pro-inflammatory cytokine interleukin 6 (IL-6). Thereby, the Pelikine Human IL-6 ELISA Rapid Kit is using the same reagents proven for specific human IL-6 detection for the last 3 decades with the renowned Pelikine compact human lL-6 ELISA kit. It further contains pre-coated ELISA plates along with an optimized, rapid protocol. The PyroCell® Monocyte Activation Test Rapid System provides the optimal tool for specific detection of the human IL-6 cytokine released by human monocytes during exposure to endotoxins or non-endotoxin pyrogens. All components together support the complete testing of 3x 96-well microtiter plates (288 tests) or up to 9 product samples according to the compendial requirements for the Monocyte Activation Test. The historical LOD of the PyroCell® Monocyte Activation Test Rapid System is ≤0.02 EU/ml. 

 

(1) European Pharmacopeia
(2) Global framework 3R

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Benefits

  • Compliant with regulatory requirements, detects the full range of pyrogens
  • Optimized components ensure robust assay performance and minimal qualification work
  • Qualified, cryopreserved PBMC pools and large batch sizes ensure reproducible results
  • Sustainable pyrogen test system replacing experimental animals and avoids the use of animal based supplements, such as FBS
  • Ensures more sensitive detection of non-endotoxin pyrogens (NEP)
  • Recommended for testing of blood based products 
  • Compatible to Lonza hardware, reagent and accessory offering

Applications

  • Pyrogen testing of raw materials, pharmaceutical preparations, medical devices
  • In-process testing for pyrogens to support development of new production processes 
  • Ideal for biological products and production processes for example, proteins, antibodies, lipid pharmaceuticals, and vaccines (TBD)

Storage and Content

  • 3 vials pMAT cells (cryopreserved, pooled PBMC). Immediately store at ≤ -80 °C 
  • 3 vials Fetal Bovine Serum Supplement (cryopreserved). Immediately store at ≤ -80 °C
  • Pelikine Human IL-6 ELISA Rapid Set A. Immediately store at ≤ -20 °C
  • Pelikine Human IL-6 ELISA Rapid Set B. Immediately store at 2-8 °C
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SDS, CoA, and Instructions

Certificate of Analysis (CoA)

Please enter Lot Number, including all zeros, located on the product label and please take into account that it is case sensitive.

  • PyroCell® MAT Kit Storage and Handling Instructions

    PyroCell® MAT Kit storage and shelf life information.
  • PyroCell™ MAT System - Quick Start Guide

    Download Quick Start Guide for the PyroCell™ MAT products
  • PyroCell® MAT Systems FAQs

    Frequently asked questions and answers about the PyroCell® MAT System and the PyroCell® MAT Human Serum System
  • PyroCell® MAT Rapid System Manual

    Instructions for how to use the PyroCell® MAT Rapid System
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Educational Material

Brochures, White Papers etc.

  • PyroCell® MAT Kit Storage and Handling Instructions

    PyroCell® MAT Kit storage and shelf life information.
  • PyroCell™ MAT System - Quick Start Guide

    Download Quick Start Guide for the PyroCell™ MAT products
  • PyroCell® MAT System Toss Sheet

    The PyroCell® Monocyte Activation Test (MAT) brings sensitive and reliable pyrogen detection to a test plate format, to ensure product safety and compliance.
  • PyroCell® MAT Systems FAQs

    Frequently asked questions and answers about the PyroCell® MAT System and the PyroCell® MAT Human Serum System
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