CBSETs bioanalytical chemistry services are scheduled to be available in Q3/2007. CBSET will provide comprehensive bioanalytical support for all stages of product development, including analysis of drug content in samples from early discovery and preclinical studies, and GLP method validation and analysis for all phases of development from safety assessment through clinical trials. Support services for programs including Toxicology, Drug Metabolism, and Clinical evaluation of pharmaceutics, biopharmaceutics, and combination products will be offered. Robotic sample preparation techniques such as automated sample extraction and high-throughput analysis will be employed to enable rapid turn around of analytical data. Assays to determine drug and metabolite concentrations in biological matrices such as plasma, serum, CSF, urine will be offered. Immunobioanalytical services dedicated to the analysis of biologics and to the development of biomarkers for disease and efficacy endpoints are also planned. Dose formulations will be analyzed on-site for determination of the concentration of test article in the support GLP preclinical studies.
Analytical Methodologies
- LC-MS/MS
- LC-MS, GC-MS
- HPLC, GC
- CE
- Immunoassay techniques such as ELISA, RIA, EIA, IRMA
- HPLC - radiomatic
Metabolite identification and profiling of radiolabeled compounds will be offered.
