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Pharma & Biotech

PyroCellTM MAT System, IL-1 beta

Catalog #: 00254715

The PyroCellTM MAT System, IL-1 beta is an all-inclusive kit to conduct the MAT assay. It combines the PyroCellTM MAT Kit and the Pelikine compact human IL-1 beta ELISA kit. It contains 3 vials of cryopreserved, pooled PBMC (pMAT Cells), 3 vials of MAT Culture Medium Supplement, the PeliKine compact human IL-1 beta kit and the PeliKine tool set 1 sufficient for 288 test (3 ELISA plate).

Contains the PyroCellTM MAT Kit and the Pelikine compact human IL-1 beta ELISA kit.

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Product Overview

The Monocyte Activation Test (MAT) is an in vitro assay for pyrogen testing in the biopharmaceutical or medical device industry. The MAT test principle is based on the detection of inflammatory cytokines released by human monocytes in response to exogenous endotoxins (LPS) and non-endotoxin pyrogens (NEP). Since its first adoption into the European Pharmacopeia in 2010 (Chapter 2.6.30) the MAT is recognized as a compendial method for pyrogen testing in a number of world regions including Europe. Here, the MAT is recommended as a replacement test for the Rabbit Pyrogen Test (RPT) (1). The MAT is further compliant to the global framework of the 3Rs principle (replacement, refinement, reduction of experimental animal tests). (2)

 

The MAT assay is performed in two steps: during an overnight cell culture step, a monocytic cell preparation, e.g. peripheral blood mononuclear cells (PBMC) 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 released cytokines using an ELISA assay. The color reaction is measured in an absorbance reader, e.g. the ELx808 Reader, at a wavelength of 450 nm and a reference wavelength of 540-590 nm. The pyrogenic content of the sample is then analyzed against the reference standard endotoxin (RSE) and is expressed in Endotoxin Equivalent Units (EEU/mL).

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

 

The following reagents, accessories and instruments support the PyroCellTM MAT System, IL-1 beta:

Step 1: Monocyte Activation 

ProductCatalog #
Iscove's Modified Dulbecco's Medium (IMDM) with L-Glutamine and HEPES12-722F
USP Reference Standard EndotoxinE700
LAL Reagent WaterW50-100
Pyrogen-free Dilution TubesN207
Reagent Reservoirs00190035
LAL Reagent GradeTM Multi-well Plates25-340
Endotoxin-free accessories, i.e. sample container,
pipette tips, serological pipettes
See Catalog

 

Step 2: IL-6 ELISA

ProductCatalog #
ELx808 Reader (with 450 and 540-590 nm filter)25-315S
Endotoxin-free accessories, i.e. sample container,
pipette tips, serological pipettes
See Catalog

 

The PyroCellTM MAT System, IL-1 beta is an all-inclusive kit containing all necessary reagents for the MAT assay: the PyroCellTM MAT Kit that contains the cryopreserved PBMC preparation pooled from 4 healthy donors (pMAT Cells) along with the MAT Culture Medium Supplement, and the PeliKine compact IL-1 beta ELISA kit that contains all reagents and buffer concentrates to conduct an IL-1 beta ELISA.  The pMAT Cells are specifically qualified for endotoxin and non-endotoxin pyrogen testing with the MAT. Thereby, donor selection, cell preparation and quality testing strictly follow the requirements outlined in Ph. Eur. Chapter 2.6.30. The MAT Culture Medium Supplement is formulated with special attention to a low endotoxin content in order to ensure error-free cell stimulation conditions. The PyroCellTM MAT system is the optimal tool for the sensitive detection of the pro-inflammatory cytokine Interleukin 1 beta (IL-1 beta) released by human monocytes during exposure to endotoxins and non-endotoxin pyrogens. The PyroCellTM MAT system, IL-1 beta is recommended for applications where an IL-6 read-out system can not be applied. All components together support the complete testing of 3x 96 well plates or up to 3 product samples per plate according to the compendial requirements for the MAT assay. Based on historical data, the LOD for the PyroCell MAT System, IL-1 beta is suggested 0.04 EU/ml however, this has to be verified by the user.

 

 

Benefits

  • Sustainable pyrogen test system avoiding the use of experimental animals
  • Compliant with regulatory requirements, detects the full range of pyrogens
  • Qualified cells ensure reliable assay performance and reproducible results
  • Optimized assay components ensure high sensitivity and minimize qualification work
  • Fully compatible to Lonza hardware

Applications

  • Pyrogen testing of raw materials, pharmaceutlical 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

Content & Storage

Content

  •  3 vials pMAT cells shipped on dry ice. Immediately store at ≤ -80°C
  • 3 vials MAT Culture Medium Supplement. Immediately store at ≤ -80°
  • 1 box PeliKine compact human IL-1 beta kit. Store at -18°C to -32°C
  • 1 box PeliKine tool set 1. Store at 2-8°C

Safety Data Sheets (SDS)

Certificate of Analysis (CoA)

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