Bioanalytical methods for the quantification of therapeutic monoclonal antibodies and their application in clinical pharmacokinetic studies.

Monoclonal antibodies (mAbs) are an upcoming group of therapeutic compounds used to treat various types of diseases. Currently more than 100 mAbs are in clinical development. To establish the pharmacokinetic (PK) properties of mAbs many (pre-)clinical studies are executed. Samples of these studies are most often analysed using immunoassays. Although immunoassays are very fast and sensitive, there are also some limitations. Alternative assays using e.g. liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS), therefore, are also being developed. This paper reviews methods for the bioanalysis of the therapeutic mAbs that are currently registered, and their application in (pre-) clinical PK studies. We will focus on immunoassays and will make the comparison with other analytical techniques. We conclude that immunoassays are still the analytical technique of first choice for the analysis of mAbs, but that, unfortunately, the provided information in the literature about method performance is scarce.