Bioanalysis, encompassing quantitation of both therapeutic and endogenous molecules
in biological samples, is a critical component of all pharmaceutical research and
development programs at Merck. During the preclinical development phase, bioanalysis
is routinely applied to determine the pharmacokinetic (PK) and pharmacodynamic
(PD) properties of drug candidates and ultimately predict outcomes in human. Assays
for protein quantitation have become increasingly needed to support the development
of monoclonal antibodies and other emerging large molecule modalities. Liquid chromatography
tandem mass spectrometry (LC-MS) has gained traction as a quantitative tool in
the discovery space where assay flexibility is needed to analyze multiple drug
candidates that may still undergo revision, all while maintaining high sensitivity,
selectivity, and short method development timelines to facilitate rapid decision
making. These attributes of LC-MS along with multiplexing capabilities also make
it well suited for larger panels of endogenous proteins that can serve as biomarkers
of drug safety or efficacy.
