SWATH data independent acquisition technology for detection of host cell protein contaminants in biopharmaceutical protein products

摘要

Systems and methods are provided for detecting host cell contaminants in a protein biotherapeutic product using sequential windowed acquisition tandem mass spectrometry. Sequential windowed acquisition is performed on a protein biotherapeutic product sample by sequentially stepping a precursor mass window across a mass range, fragmenting transmitted precursor ions of each stepped precursor mass window, and analyzing product ions produced from the fragmented transmitted precursor ions. The sequential windowed acquisition is performed without any information about contaminating proteins before data acquisition, and produces data for every product ion of every transmitted precursor ion for the mass range. One or more measured product ion spectra are received, and compared to a library of host cell proteins. One or more host cell contaminants are detected by reporting host cell proteins from the library that match the one or more measured product ion spectra.