3P-06 PDF
Ultra-sensitive host cell protein quantification using CESI-SWATH Acquisition MS
Host cell proteins (HPCs) are undesired impurities in biologic preparation processes and can negatively affect biotherapeutic quality, potency, and safety. Identification and quantification of HPCs within therapeutic monoclonal antibody (mAb) preparations remain a challenge with a need for improved sensitivity and specificity. Mass spectrometry, particularly data-independent acquisition such as provided by SWATH™ acquisition, provides a robust and sensitive means to quantify HCPs in the parts-per-million (ppm) range. The integration of capillary electrophoresis (CE) and electrospray ionization (ESI) into one process (CESI) presents the possibility to improve the sensitivity of HCP quantitation through reduced ion suppression at ultralow nanoliter per minute flow rates. We describe use of CESI-SWATH acquisition for the ultrasensitive quantitation of HCPs in a representative therapeutic mAb preparation.