Comprehensive tracking of host cell proteins during monoclonal antibody purifications using mass spectrometry.

ABSTRACT: An advanced two-dimensional liquid chromatography/mass spectrometry platform was used to quantify individual host cell proteins (HCPs) present at various purification steps for several therapeutic monoclonal antibodies (mAbs) produced in Chinese hamster ovary cells. The methodology produced reproducible identifications and quantifications among replicate analyses consistent with a previously documented individual limit of quantification of ~13 ppm. We were able to track individual HCPs from cell culture fluid to protein A eluate pool to subsequent viral inactivation pool and, in some cases, further downstream. Approximately 500 HCPs were confidently identified in cell culture fluid and this number declined progressively through the purification scheme until no HCPs could be confidently ide

SUBMITTER: Zhang Q 

PROVIDER: S-EPMC4011910 | biostudies-literature | 2014 May-Jun

REPOSITORIES: biostudies-literature