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Pharma & Biotech

PyroCellTM MAT System, IL-6

Catalog #: 00254714

The PyroCellTM MAT System, IL-6 is an all-inclusive kit to conduct the MAT assay. It combines the PyroCellTM MAT Kit and the Pelikine compact human IL-6 ELISA kit. It contains 3 vials of cryopreserved, pooled PBMC (pMAT Cells), 3 vials of MAT Culture Medium Supplement, the PeliKine compact human IL-6 kit and the PeliKine tool set 1 sufficient for 288 test (3 ELISA plate).

Contains PyroCellTM MAT Kit and Pelikine compact human IL-6 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).

 

The following reagents, accessories and instruments support the PyroCellTM MAT System, IL-6:

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-6 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 human IL-6 ELISA kit that contains all reagents and buffer concentrates to conduct an IL-6 ELISA.  The pMAT Cells are specifically qualified for endotoxins and non-endotoxin pyrogen testing with the MAT. Thereby, donor selection, cell preparation and quality testing strictly follow the requirements outlined in the 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 Kit has been validated for use with the PeliKine compact human IL-6 ELISA kit for sensitive detection of the released pro-inflammatory cytokine interleukin 6 (IL-6). Therefore, the PyroCellTM MAT system is the optimal tool for the sensitive detection of the IL-6 cytokine released by human monocytes during exposure to endotoxins or pyrogens. All components together support the complete testing of 3x 96 well plates or up to 9 product samples according to the compendial requirements for the MAT assay. The historical LOD of the PyroCellTM MAT System, IL-6 is 0.02 EU/ml.

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

 

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-6 kit. Store at -18°C to -32°C 
  • 1 box PeliKine tool set 1. Store at 2-8°C

Instructions

Safety Data Sheets (SDS)

Certificate of Analysis (CoA)

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