August 31, 2011-

Coagulation Factor Measurement to Support Toxicokinetic Analysis

The Clinical Pathology Department at Charles River Montreal recently analyzed a compound known to be a recombinant coagulation factor. It represents the first time a recombinant coagulation factor’s biological activity has been analyzed within our clinical laboratory. Overall, the analytical method used is one of many our multiple preclinical laboratories aim to expand on.

To assess the activity of this specific recombinant coagulation factor, toxicokinetic (TK) samples from toxicology studies were analyzed. The analytical method was applied to one of our standard coagulation analyzers within the clinical laboratory and the results of the factor’s activity were analyzed and reported by the TK group. The analytical method was adapted from the sponsor and is fully validated.

Bone Marrow Cytology Assessment

When there are indications of hematotoxicity in a toxicity study, cytological assessment of bone marrow smears can provide valuable information. Veterinary clinical pathologists at Charles River Montreal were involved in a recent publication titled “Best practices for the evaluation of bone marrow in non-clinical toxicity studies,” which appeared in a recent issue of The Journal of Toxicologic Pathology (Reagan et al, 2011).

In the evaluation of bone marrow smears a quantitative assessment–typically a 300 cell count–is performed. The quantitative assessment also includes a calculation of the myeloid to erythroid ratio. In addition, an evaluation involves a qualitative assessment. This aspect provides information on cellular morphology as well as maturation of hematopoietic cell lineages. At the conclusion of an evaluation, a bone marrow report is provided with an interpretation of the data, which includes correlations with any potential findings within the hematology and anatomic pathology results. This service is available at all Charles River Preclinical Services laboratories.

For additional information on this study or our clinical chemistry capabilities, please contact us at 1.877.CRIVER.1 or askcharlesriver@crl.com.