2P-45 PDF
LC/MS/MSによる生体試料中バイオ後続品の定量法の評価
The development of antibody drugs including biosimilar is further accelerated. Conventionally, ligand binding assay (LBA) has been used for the quantification of the concentration of antibody drugs in biological samples. However, the quantification method using liquid chromatography tandem mass spectrometry (LC/MS/MS) is getting attention as alternative method to LBA. In terms of LBA, it takes a long time to develop analytical method because of the preparing the specific antibody that bind to antibody drug. On the other hand, in the LC/MS/MS method, it is possible to construct a measurement system in relatively short time because of unrequiring the specific antibody. This shorter lead time enables prompt non-clinical evaluation after the process establishment of the biosimilar product. As general method of measurement by LC/MS/MS, after enzymatic digestion of antibody drugs and addition of internal standard (IS) peptide labeled with stable isotope, the specific peptide fragment and IS are measured with selected reaction monitoring (SRM). In this presentation, we introduce the study result of LC/MS/MS quantitative system using a universal IS, widely applied to many antibody drugs, and magnetic beads for recovery of IgG.