endotoxin & pyrogenicity

Endotoxin and pyrogen detection is vital step for you to gain market approval for your product. Charles River Biopharmaceutical Services (BPS) offers this service as part of our process manufacturing support network.
Endotoxin Testing
Our in vitro bacterial endotoxin testing, including gel-clot (qualitative), kinetic turbidimetric and chromogenic methods (quantitative), are carried out to meet all pharmacopoeia requirements. We provide preliminary screening and validation of products as well as a backup technical service. Test results are available within one to three days.
In addition, our Endotoxin and Microbial Detection group offers a line of rapid testing systems, which includes assays for fast and easy endotoxin analysis, glucan contamination, Gram determination and protein concentration.
Pyrogenicity Testing
We have extensive experience conducting in vivo pyrogenicity testing. To support this testing, newly refurbished, dedicated, pyrogen testing facilities are available.
Monocyte Activation Test
The monocyte activation test (MAT) is used to detect or quantify substances that activate human monocytes or monocytic cells to release endogenous mediators. It has been added to the portfolio offered by BPS following the recent changes to the European Pharmacopeia monograph (04/2010:20630). Charles River offers the assessment of pyrogenicity by quantifying the release of IL-1β from cryopreserved human blood (ELISA). A panel of cytokines, including tumor necrosis factor alpha (TNFα), interleukin-6 (IL-6) and interleukin-8 (IL-8), can also be included for assessment.