Description
Product Overview The Monocyte Activation Test (MAT) is an in vitro assay for pyrogen testing in pharmaceutical and medical device industries. The principle of the Monocyte Activation Test 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 by the European Pharmacopeia in 2010 (Ph. Eur. chapter 2.6.30) the Monocyte Activation Test is recognized as a compendial method for pyrogen testing in several world regions including Europe. Here, the Monocyte Activation Test is suggested to replace the Rabbit Pyrogen Test (RPT) (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 sample to be tested for the presence of pyrogens. On the next day, the cell culture supernatant is analyzed for released human IL-6 cytokines using the Pelikine Human IL-6 Rapid ELISA assay . The color reaction is measured with an absorbance reader, e.g the Nebula® Absorbance Reader or the Nebula® Multimode Reader at a wavelength of 450nm and a reference wavelength of 540-590nm. 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-Human Serum Rapid System is an all-inclusive kit containing validated reagents for the Monocyte Activation Test: the PyroCell® Monocyte Activation Test (PyroCell® MAT Kit) that contains the cryopreserved, human PBMC preparation pooled from 4 healthy human blood donations (pMAT Cells) along with an optimized Human Serum 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 Human Serum component is formulated with special attention to low endotoxin content in order to ensure error-free cell stimulation conditions. Using Human Serum in the cell culture step of the Monocyte Activation Tests provides benefits as compared to the PyroCell® Monocyte Activation Test Rapid System – FBS System: it avoids the use of an animal based resource and is therefore, the more sustainable solution. If used in a Monocyte Activation Test with blood-derived products possible interferences may be overcome with less dilutions. Finally, the flexible use of different supplements with pMAT cells is supporting finding the optimal conditions during a product-specific validation. 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 – Human Serum 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 – Human Serum Rapid System is ≤0.08 EU/ml. (1) European Pharmacopeia (2) Global framework 3R Request More Info
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 Human 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
