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SWATH-MS as a strategy for CHO host cell protein identification and quantification supporting the characterization of mAb purification platforms

2024-03-20Artigo científico Acesso aberto
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dc.contributor.authorCarvalho, Sofia B.
dc.contributor.authorProfit, Ludivine
dc.contributor.authorKrishnan, Sushmitha
dc.contributor.authorGomes, Ricardo A.
dc.contributor.authorAlexandre, Bruno M.
dc.contributor.authorClavier, Severine
dc.contributor.authorHoffman, Michael
dc.contributor.authorBrower, Kevin
dc.contributor.authorGomes-Alves, Patrícia
dc.contributor.institutionInstituto de Tecnologia Química e Biológica António Xavier (ITQB)
dc.contributor.pblElsevier
dc.date.accessioned2025-05-07T21:17:18Z
dc.date.available2025-05-07T21:17:18Z
dc.date.issued2024-03-20
dc.descriptionFunding Information: This work was supported by Sanofi. Funding Information: Authors acknowledge the support from the UniMS team, all MS data were generated by the UniMS–Mass Spectrometry Unit, iBET/ITQB, Oeiras, Portugal. The authors also acknowledge Miguel Antunes and Inês Isidro from iBET Data Science team for their contribution to data analysis. The authors acknowledge the experimental work from Emmanuel Fofie, Céline Hemet and Didier Duthé from Sanofi on chromatographic runs. The authors are grateful to Jason Walther for revising the manuscript and English proofreading. Publisher Copyright: © 2024 The Authors
dc.description.abstractHost cell proteins (HCPs) are process-related impurities expressed by the host cells during biotherapeutics’ manufacturing, such as monoclonal antibodies (mAbs). Some challenging HCPs evade clearance during the downstream processing and can be co-purified with the molecule of interest, which may impact product stability, efficacy, and safety. Therefore, HCP content is a critical quality attribute to monitor and quantify across the bioprocess. Here we explored a mass spectrometry (MS)-based proteomics tool, the sequential window acquisition of all theoretical fragment-ion spectra (SWATH) strategy, as an orthogonal method to traditional ELISA. The SWATH workflow was applied for high-throughput individual HCP identification and quantification, supporting characterization of a mAb purification platform. The design space of HCP clearance of two polishing resins was evaluated through a design of experiment study. Absolute quantification of high-risk HCPs was achieved (reaching 1.8 and 4.2 ppm limits of quantification, for HCP A and B respectively) using HCP-specific synthetic heavy labeled peptide calibration curves. Profiling of other HCPs was also possible using an average calibration curve (using labeled peptides from different HCPs). The SWATH approach is a powerful tool for HCP assessment during bioprocess development enabling simultaneous monitoring and quantification of different individual HCPs and improving process understanding of their clearance.en
dc.description.versionpublishersversion
dc.description.versionpublished
dc.format.extent11
dc.format.extent3568448
dc.identifier.doi10.1016/j.jbiotec.2024.02.001
dc.identifier.issn0168-1656
dc.identifier.otherPURE: 90453784
dc.identifier.otherPURE UUID: bac6b6ea-af05-4789-9324-c5f4852013f0
dc.identifier.otherScopus: 85185552306
dc.identifier.otherPubMed: 38340900
dc.identifier.urihttp://hdl.handle.net/10362/182734
dc.identifier.urlhttps://www.scopus.com/pages/publications/85185552306
dc.language.isoeng
dc.peerreviewedyes
dc.subjectBioprocess development
dc.subjectCHO HCP identification
dc.subjecthigh throughput HCP quantification
dc.subjectmAbs
dc.subjectPurification platform
dc.subjectSWATH-MS
dc.subjectBiotechnology
dc.subjectBioengineering
dc.subjectApplied Microbiology and Biotechnology
dc.titleSWATH-MS as a strategy for CHO host cell protein identification and quantification supporting the characterization of mAb purification platformsen
dc.typejournal article
degois.publication.firstPage1
degois.publication.lastPage11
degois.publication.titleJournal of Biotechnology
degois.publication.volume384
dspace.entity.typePublication
rcaap.rightsopenAccess

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