Endotoxin & MAT Through the Charles River process manufacturing support network, endotoxin and pyrogenicity testing can be performed in conjunction with other assays meant to detect potential contaminants in products and raw materials. This testing is a vital step in gaining market approval for products. A number of different testing methods are offered to ensure that clients are able to select the option most conducive to their pyrogen and endotoxin detection needs. Endotoxin Testing Monocyte Activation Testing Qualitative and quantitative methods available Methods meet all pharmacopoeia requirements Test results available in 1-3 days Provides preliminary screening Testing and validation of methods for specific products In vitro alternative to the in vivo pyrogenicity testing method Follows EP 2.6.30 guidelines Works by detection of the fever-inducing signal molecule interleukin-1 beta (IL-1β) Tests for Gram-positive and Gram-negative organisms, other biological pyrogens (e.g., yeast) and parasitic and viral pyrogens Quantitative or semi-quantitative Test can be used with products where testing via another method is not possible (e.g., turbidimetric substances, antipyretic drugs and immunoglobulins) Product-specific validations and comparability studies with the in vivo pyrogen testing method available You may also be interested in... Release Testing Release testing services for bulk drug substances and clinical and marketed products for the European Union (EU), United States (US) and other regulatory-distinct markets. Rapid Endotoxin Testing Line of rapid testing systems for fast and easy endotoxin analysis. Cell Line Characterization Services Design and execution of a complete testing program for your cell line that is customized to meet your exact specifications and is compliant with international regulatory guidelines. In Vivo Biosafety Testing In vivo studies required to meet biosafety regulatory requirements.
Qualitative and quantitative methods available Methods meet all pharmacopoeia requirements Test results available in 1-3 days Provides preliminary screening Testing and validation of methods for specific products
In vitro alternative to the in vivo pyrogenicity testing method Follows EP 2.6.30 guidelines Works by detection of the fever-inducing signal molecule interleukin-1 beta (IL-1β) Tests for Gram-positive and Gram-negative organisms, other biological pyrogens (e.g., yeast) and parasitic and viral pyrogens Quantitative or semi-quantitative Test can be used with products where testing via another method is not possible (e.g., turbidimetric substances, antipyretic drugs and immunoglobulins) Product-specific validations and comparability studies with the in vivo pyrogen testing method available
Release Testing Release testing services for bulk drug substances and clinical and marketed products for the European Union (EU), United States (US) and other regulatory-distinct markets.
Cell Line Characterization Services Design and execution of a complete testing program for your cell line that is customized to meet your exact specifications and is compliant with international regulatory guidelines.