Host cell protein quantification workflow using optimized standards combined with data-independent acquisition mass spectrometry.

ABSTRACT: Monitoring of host cell proteins (HCPs) during the manufacturing of monoclonal antibodies (mAb) has become a critical requirement to provide effective and safe drug products. Enzyme-linked immunosorbent assays are still the gold standard methods for the quantification of protein impurities. However, this technique has several limitations and does, among others, not enable the precise identification of proteins. In this context, mass spectrometry (MS) became an alternative and orthogonal method that delivers qualitative and quantitative information on all identified HCPs. However, in order to be routinely implemented in biopharmaceutical companies, liquid chromatography-MS based methods still need to be standardized to provide highest sensitivity and robust and accurate quantification. Here

SUBMITTER: Hessmann S 

PROVIDER: S-EPMC10257144 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature