LC/MS quantitation of biotherapeutics has evolved as a differentiated tool supporting investigative toxicology. Research demonstrates this methodology 1.) satisfies FDA criteria for TK assessments; 2.) addresses limitations of ligand binding assays techniques related to selectivity of endogenous analogs and metabolites; and 3.) mitigates reagent generation issues.
The rationale and advantages to using LC/MS-based quantitation methodologies, compared to traditional large molecule quantitation approaches, will be explored. Case studies will be presented which illustrate complementary results obtained by using parallel LC/MS and standard assay methods. Considerations for LC/MS quantitation in preclinical toxicology will be discussed.
- Elizabeth Groeber, PhD, Director, Bioanalytical Chemistry, Charles River
- Scott Fountain, PhD, Executive Director, North American Laboratory Sciences, Charles River