PRE-CLINICAL PK/TK CASE STUDY

CHALLENGE

Previous CRO failed to transfer non-human primate (NHP) PK assay for a biologic in Cerebral Spinal Fluid (CSF). CRO lacked troubleshooting expertise in ECL platform and familiarity with CSF as a matrix.

SOLUTION

KCAS has experience with ECL platform and CSF matrix and successfully transferred and validated the NHP CSF assay in proposed 8 week timeline. While transferring assay sample dilution buffer was identified as cause of previous failure to transfer.

RESULTS

Transferred and Validated assay in 8 weeks. Developed sample dilution buffer for validation of assay that was cost effective and compliant with industry guidelines.

BONUS INFORMATION

KCAS was contracted and successfully validated  Pre-clinical PK assay in plasma and brain homogenate for the same biologic.

KCAS Bioanalytical & Biomarker Services is a contract research organization (CRO) with 35+ years of bioanalytical and immunoanalytical expertise. We specialize in the development and validation of robust small, large molecule and biomarker methods for discovery, preclinical and clinical studies.

KCAS Bioanalytical & Biomarker Services | kcasbio.com | contact us: info@kcasbio.com´╗┐