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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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Comparing different domains of analysis for the characterisation of N-glycans on monoclonal antibodies

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Journal of Pharmaceutical Analysis 2020年第1期10卷 23-34页

作者： Sara Carillo Raquel Peerez-Robles craig jakes Meire Ribeiro da Silva Silvia Millan Martín Amy Farrell Natalia Navas Jonathan Bones Characterisation and Comparability Laboratory NIBRT e the National Institute for Bioprocessing Research and TrainingFoster AvenueMount MerrionBlackrockCo.DublinA94 X099Ireland Department of Analytical Chemistry Biohealth Research Institute(ibs.GRANADA)University of GranadaGranadaSpain School of Chemical and Bioprocess Engineering University College DublinBelfieldDublin 4D04 V1W8Ireland

With the size of the biopharmaceutical market exponentially increasing,there is an aligned growth in the importance of data-rich analyses,not only to assess drug product safety but also to assist drug development driven by the deeper understanding of structure/function relationships.In monoclonal antibodies,many functions are regulated by N-glycans present in the constant region of the heavy chains and their mechanisms of action are not completely known.The importance of their function focuses analytical research efforts on the development of robust,accurate and fast methods to support drug development and quality control.Released N-glycan analysis is considered as the gold standard for glycosylation characterisation;however,it is not the only method for quantitative analysis of glycoform heterogeneity.In this study,ten different analytical workflows for N-glycan analysis were compared using four monoclonal antibodies.While observing good comparability between the quantitative results generated,it was possible to appreciate the advantages and disadvantages of each technique and to summarise all the observations to guide the choice of the most appropriate analytical workflow according to application and the desired depth of data generated.

关键词： N-Glycans Biopharmaceuticals Monoclonal antibodies Intact mass analysis Mass spectrometry Native mass spectrometry Glycan analysis Peptide mapping Glycopeptide analysis

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