3P-03 PDF
アダリムマブ（ヒュミラ）とインフリキシマブ（レミケード）のヒト血漿中定量測定のためのImmunocapture-LC-MS/MSワークフロー
Adalimumab (trade name Humira) is a monoclonal antibody (mAb) used widely to treat rheumatoid arthritis, psoriatic arthritis and many other autoimmune diseases, by binding to tumor necrosis factor-alpha (TNF-α) and reduce the inflammatory response. Another top selling mAb drug is Infliximab (Remicade) which is used for Crohn's disease. To maximize treatment efficiency and maintain drug remission, plasma adalimumab levels need to be accurately quantified in preclinical and clinical analysis. Although enzyme-linked immunosorbent assays (ELISAs) have been applied as the traditional standard methods for mAb quantitation, the method development suffers with the dependence on custom regent, and matrix interference. Herein, we introduce a universal total solution combining sample preparation and mass spectrometric analysis for adalimumab and infliximab quantitation in human plasma.Using the MRM acquisition technique on the QTRAP 6500 System, we achieved high sensitivity detection and robust quantitation of adalimumab and infliximab in human plasma samples.
Calibration curves of adalimumab or infliximab standards in human plasma matrix (5 - 2000 ng/mL) were generated using MultiQuant™ Software. The limit of quantification (LOQ) for both monoclonal antibodies was at the lowest measured concentration, 5 ng/mL. Linearity was achieved from 5 to 2000 ng/mL with regression coefficient (r2) of at least 0.99922. For all calibration standards for adalimumab or infliximab, a coefficient of variance (CV) was less than 10% and accuracy was within 10%.