Optimized sample preparation, data processing of data-independent acquisition methods for the robust quantification of trace-level host cell protein impurities in drug products

ABSTRACT: In this study, we developed powerful and reproducible MS-based analytical workflows coupling optimized and efficient sample preparations, library-free DIA acquisition method and stringent validation criteria. The performances of several preparation protocols and DIA versus classical DDA were evaluated using a series of four commercially available Drug Products. Depending on the selected protocols, the user has access to different information: on the one hand, a deep profiling of tens of identified HCPs, and on the other hand an accurate and reproducible (CV<12%) quantification of major HCPs. Overall, a final global HCP amount of a few tens of ppm in these mAb samples was measured, while reaching a sensitivity down to the sub-ppm level. Thus, this straightforward and robust approach can be intended as a routine quality control for whichever Drug Products’ analysis.

INSTRUMENT(S):

ORGANISM(S): Cricetulus Griseus (chinese Hamster) (cricetulus Barabensis Griseus)

TISSUE(S): Cell Culture

SUBMITTER: Nicolas Pythoud  

LAB HEAD: Christine Carapito

PROVIDER: PXD019668 | Pride | 2020-10-19

REPOSITORIES: Pride