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.

  • Qualitative and quantitative methods available
  • Methods meet all pharmacopoeial 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

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