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Detection and quantitation of host cell proteins in monoclonal antibody drug products using automated sample preparation and data-independent acquisition LC-MS/MS

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Journal of Pharmaceutical Analysis 2021年第6期11卷 726-731页

作者： Lisa Strasser Giorgio Oliviero Craig Jakes izabela zaborowska Patrick Floris Meire Ribeiro da Silva Florian Füssl Sara Carillo Jonathan Bones Characterization and Comparability Laboratory NIBRT-National Institute for Bioprocessing Research and TrainingDublinA94 X099Ireland School of Chemical and Bioprocess Engineering University College DublinDublinD04 V1W8Ireland

Ensuring the removal of host cell proteins(HCPs) during downstream processing of recombinant proteins such as monoclonal antibodies(m Abs) remains a challenge.Since residual HCPs might affect product stability or safety,constant monitoring is required to demonstrate their removal to be below the regulatory accepted level of 100 ng/mg.The current standard analytical approach for this procedure is based on ELISA;however,this approach only measures the overall HCP content.Therefore,the use of orthogonal methods,such as liquid chromatography-mass spectrometry(LC-MS),has been established,as it facilitates the quantitation of total HCPs as well as the identification and quantitation of the individual HCPs present.In the present study,a workflow for HCP detection and quantitation using an automated magnetic bead-based sample preparation,in combination with a data-independent acquisition(DIA) LC-MS analysis,was established.Employing the same instrumental setup commonly used for peptide mapping analysis of m Abs allows for its quick and easy implementation into pre-existing workflows,avoiding the need for dedicated instrumentation or personnel.Thereby,quantitation of HCPs over a broad dynamic range was enabled to allow monitoring of problematic HCPs or to track changes upon altered bioprocessing conditions.

关键词： Data-independent acquisition Host cell proteins Critical quality attributes Liquid chromatography-mass spectrometry Monoclonal antibody Chinese hamster ovary cells

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