{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T12:21:45Z","timestamp":1783081305462,"version":"3.54.6"},"reference-count":39,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,5,8]],"date-time":"2026-05-08T00:00:00Z","timestamp":1778198400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100012774","name":"Innovation Fund Denmark","doi-asserted-by":"publisher","award":["3129\\u201300022B"],"award-info":[{"award-number":["3129\\u201300022B"]}],"id":[{"id":"10.13039\/100012774","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Pharmaceutical and Biomedical Analysis"],"published-print":{"date-parts":[[2026,9]]},"DOI":"10.1016\/j.jpba.2026.117555","type":"journal-article","created":{"date-parts":[[2026,5,9]],"date-time":"2026-05-09T23:09:26Z","timestamp":1778368166000},"page":"117555","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"special_numbering":"C","title":["Illuminating the Dark Host Cell Proteome: A host cell protein coverage method for LC-MS impurity assays"],"prefix":"10.1016","volume":"278","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-2121-4066","authenticated-orcid":false,"given":"Victor G.","family":"Chrone","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mads","family":"Kofoed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anette H.","family":"Draborg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Veit","family":"Schw\u00e4mmle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Kofoed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"H\u00f8jrup","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4381-1546","authenticated-orcid":false,"given":"Ejvind","family":"M\u00f8rtz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"4","key":"10.1016\/j.jpba.2026.117555_bib1","doi-asserted-by":"crossref","first-page":"583","DOI":"10.1016\/j.molcel.2013.01.029","article-title":"The coming age of complete, accurate, and ubiquitous proteomes","volume":"49","author":"Mann","year":"2013","journal-title":"Mol. Cell"},{"issue":"D1","key":"10.1016\/j.jpba.2026.117555_bib2","doi-asserted-by":"crossref","first-page":"D442","DOI":"10.1093\/nar\/gky1106","article-title":"The PRIDE database and related tools and resources in 2019: improving support for quantification data","volume":"47","author":"Perez-Riverol","year":"2019","journal-title":"Nucleic Acids Res."},{"issue":"7620","key":"10.1016\/j.jpba.2026.117555_bib3","doi-asserted-by":"crossref","first-page":"347","DOI":"10.1038\/nature19949","article-title":"Mass-spectrometric exploration of proteome structure and function","volume":"537","author":"Aebersold","year":"2016","journal-title":"Nature"},{"issue":"12","key":"10.1016\/j.jpba.2026.117555_bib4","doi-asserted-by":"crossref","first-page":"5296","DOI":"10.1021\/acs.jproteome.4c00776","article-title":"The 2024 report on the human proteome from the HUPO Human Proteome Project","volume":"23","author":"Omenn","year":"2024","journal-title":"J. Proteome Res."},{"issue":"3","key":"10.1016\/j.jpba.2026.117555_bib5","doi-asserted-by":"crossref","first-page":"499","DOI":"10.1038\/s41592-024-02558-2","article-title":"Enhanced sensitivity and scalability with a Chip-Tip workflow enables deep single-cell proteomics","volume":"22","author":"Ye","year":"2025","journal-title":"Nat. Methods"},{"issue":"1","key":"10.1016\/j.jpba.2026.117555_bib6","doi-asserted-by":"crossref","DOI":"10.1093\/bioadv\/vbaf301","article-title":"Perspectives in computational mass spectrometry: recent developments and key challenges","volume":"5","author":"Sachsenberg","year":"2025","journal-title":"Bioinform. Adv."},{"issue":"8","key":"10.1016\/j.jpba.2026.117555_bib7","doi-asserted-by":"crossref","DOI":"10.1016\/j.mcpro.2024.100800","article-title":"Data-independent acquisition: a milestone and prospect in clinical mass spectrometry-based proteomics","volume":"23","author":"Fr\u00f6hlich","year":"2024","journal-title":"Mol. Cell. Proteom."},{"key":"10.1016\/j.jpba.2026.117555_bib8","unstructured":"Committee for Medicinal Products for Human Use (CHMP), ICH Q2(R2) guideline on validation of analytical procedures, European Medicines Agency, 2023. \u3008https:\/\/www.ema.europa.eu\/en\/ich-q2r2-validation-analytical-procedures-scientific-guideline\u3009 (accessed Jan. 19, 2026)."},{"key":"10.1016\/j.jpba.2026.117555_bib9","unstructured":"Committee for Medicinal Products for Human Use (CHMP), ICH Q14 guideline on analytical procedure development, European Medicines Agency, 2023. \u3008https:\/\/www.ema.europa.eu\/en\/ich-q14-analytical-procedure-development-scientific-guideline\u3009 (accessed Jan. 19, 2026)."},{"key":"10.1016\/j.jpba.2026.117555_bib10","doi-asserted-by":"crossref","DOI":"10.1016\/j.jpba.2025.117051","article-title":"Host cell protein quantitation by LC-MS: experimental demonstration, qualification, and comparison of methods in USP 1132.1","volume":"265","author":"Chrone","year":"2025","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.jpba.2026.117555_bib11","unstructured":"U.S. Pharmacopeia (USP), <1132.1> Residual host cell protein measurement in biopharmaceuticals by liquid chromatography\u2013mass spectrometry, United States Pharmacopeial Convention, Rockville, MD, 2025. \u3008https:\/\/doi.usp.org\/USPNF\/USPNF_M17756_02_01.html\u3009 (accessed Jan. 19, 2026)."},{"key":"10.1016\/j.jpba.2026.117555_bib12","article-title":"HCP control by state-of-the-art technologies in the product life cycle","author":"Friedl","year":"2025","journal-title":"Present. Biopharm. Emerg. Best. Pract. Assoc. (BEBPA) Lake Bled Slov."},{"issue":"2","key":"10.1016\/j.jpba.2026.117555_bib13","doi-asserted-by":"crossref","first-page":"747","DOI":"10.1007\/s00216-021-03648-2","article-title":"Monitoring process-related impurities in biologics\u2013host cell protein analysis","volume":"414","author":"Pilely","year":"2022","journal-title":"Anal. Bioanal. Chem."},{"issue":"8","key":"10.1016\/j.jpba.2026.117555_bib14","doi-asserted-by":"crossref","first-page":"2870","DOI":"10.1002\/bit.27808","article-title":"High-risk\u2019 host cell proteins (HCPs): a multi-company collaborative view","volume":"118","author":"Jones","year":"2021","journal-title":"Biotechnol. Bioeng."},{"key":"10.1016\/j.jpba.2026.117555_bib15","doi-asserted-by":"crossref","first-page":"3229","DOI":"10.1002\/bit.70029","article-title":"Host cell protein clinical safety risk assessment \u2014 an updated industry review","volume":"122","author":"Coye","year":"2025","journal-title":"Biotechnol. Bioeng."},{"issue":"12","key":"10.1016\/j.jpba.2026.117555_bib16","doi-asserted-by":"crossref","first-page":"5227","DOI":"10.1021\/acs.jproteome.1c00590","article-title":"Progress identifying and analyzing the human proteome: 2021 metrics from the HUPO Human Proteome Project","volume":"20","author":"Omenn","year":"2021","journal-title":"J. Proteome Res."},{"issue":"4","key":"10.1016\/j.jpba.2026.117555_bib17","doi-asserted-by":"crossref","DOI":"10.1002\/btpr.2983","article-title":"A novel approach to evaluate ELISA antibody coverage of host cell proteins \u2014 combining ELISA-based immunocapture and mass spectrometry","volume":"36","author":"Pilely","year":"2020","journal-title":"Biotechnol. Prog."},{"key":"10.1016\/j.jpba.2026.117555_bib18","series-title":"European Pharmacopoeia 11.1","article-title":"European Directorate for the Quality of Medicines & HealthCare (EDQM)","year":"2023"},{"key":"10.1016\/j.jpba.2026.117555_bib19","unstructured":"United States Pharmacopeia (USP), <1132> Residual host cell protein measurement in biopharmaceuticals, USP 39\u2013NF 34, United States Pharmacopeial Convention, Rockville, MD, 2016. \u3008https:\/\/doi.usp.org\/USPNF\/USPNF_M8647_01_01.html\u3009 (accessed Jan. 19, 2026)."},{"key":"10.1016\/j.jpba.2026.117555_bib20","doi-asserted-by":"crossref","first-page":"2709","DOI":"10.1021\/acs.jproteome.4c00973","article-title":"To fly, or not to fly, that is the question: a deep learning model for peptide detectability prediction in mass spectrometry","volume":"24","author":"Abdul-Khalek","year":"2025","journal-title":"J. Proteome Res."},{"issue":"2","key":"10.1016\/j.jpba.2026.117555_bib21","doi-asserted-by":"crossref","first-page":"526","DOI":"10.1021\/acs.jproteome.2c00538","article-title":"PeptideRanger: an R package to optimize synthetic peptide selection for mass spectrometry applications","volume":"22","author":"Riley","year":"2023","journal-title":"J. Proteome Res."},{"issue":"30","key":"10.1016\/j.jpba.2026.117555_bib22","doi-asserted-by":"crossref","first-page":"11193","DOI":"10.1021\/acs.analchem.3c00460","article-title":"DbyDeep: exploration of MS-detectable peptides via deep learning","volume":"95","author":"Son","year":"2023","journal-title":"Anal. Chem."},{"issue":"52","key":"10.1016\/j.jpba.2026.117555_bib23","doi-asserted-by":"crossref","first-page":"15898","DOI":"10.1073\/pnas.1508380112","article-title":"Unexpected features of the dark proteome","volume":"112","author":"Perdig\u00e3o","year":"2015","journal-title":"Proc. Natl. Acad. Sci. U. S. A."},{"key":"10.1016\/j.jpba.2026.117555_bib24","unstructured":"Alphalyse A\/S, HCPedia, \u3008https:\/\/hcpedia.com\/\u3009 (accessed 13 January 2026)."},{"issue":"1","key":"10.1016\/j.jpba.2026.117555_bib25","doi-asserted-by":"crossref","first-page":"105","DOI":"10.1016\/0022-2836(82)90515-0","article-title":"A simple method for displaying the hydropathic character of a protein","volume":"157","author":"Kyte","year":"1982","journal-title":"J. Mol. Biol."},{"issue":"1","key":"10.1016\/j.jpba.2026.117555_bib26","doi-asserted-by":"crossref","first-page":"10","DOI":"10.1016\/0307-4412(85)90114-1","article-title":"Amino acid and peptide net charges: a simple calculational procedure","volume":"13","author":"Moore","year":"1985","journal-title":"Biochem. Educ."},{"issue":"10","key":"10.1016\/j.jpba.2026.117555_bib27","doi-asserted-by":"crossref","first-page":"1023","DOI":"10.1002\/elps.11501401163","article-title":"The focusing positions of polypeptides in immobilized pH gradients can be predicted from their amino acid sequences","volume":"14","author":"Bjellqvist","year":"1993","journal-title":"Electrophoresis"},{"issue":"10","key":"10.1016\/j.jpba.2026.117555_bib28","doi-asserted-by":"crossref","first-page":"1419","DOI":"10.1074\/mcp.R500012-MCP200","article-title":"Interpretation of shotgun proteomic data","volume":"4","author":"Nesvizhskii","year":"2005","journal-title":"Mol. Cell. Proteom."},{"issue":"17","key":"10.1016\/j.jpba.2026.117555_bib29","doi-asserted-by":"crossref","first-page":"4646","DOI":"10.1021\/ac0341261","article-title":"A statistical model for identifying proteins by tandem mass spectrometry","volume":"75","author":"Nesvizhskii","year":"2003","journal-title":"Anal. Chem."},{"issue":"1","key":"10.1016\/j.jpba.2026.117555_bib30","doi-asserted-by":"crossref","first-page":"71","DOI":"10.1002\/cfg.235","article-title":"The gene ontology annotation (GOA) project\u2014application of GO in SWISS-PROT, TrEMBL and InterPro","volume":"4","author":"Camon","year":"2003","journal-title":"Comp. Funct. Genom."},{"issue":"12","key":"10.1016\/j.jpba.2026.117555_bib31","doi-asserted-by":"crossref","first-page":"3811","DOI":"10.1016\/j.xphs.2021.08.024","article-title":"A highly sensitive LC-MS\/MS method for targeted quantitation of lipase host cell proteins in biotherapeutics","volume":"110","author":"Chen","year":"2021","journal-title":"J. Pharm. Sci."},{"issue":"3","key":"10.1016\/j.jpba.2026.117555_bib32","doi-asserted-by":"crossref","first-page":"1632","DOI":"10.1073\/pnas.77.3.1632","article-title":"Prediction of peptide retention times in high-pressure liquid chromatography on the basis of amino acid composition","volume":"77","author":"Meek","year":"1980","journal-title":"Proc. Natl. Acad. Sci. U. S. A."},{"key":"10.1016\/j.jpba.2026.117555_bib33","series-title":"Amino Acids, Peptides and Proteins in Organic Chemistry, Vol. 5: Analysis and Function of Amino Acids and Peptides","first-page":"1","article-title":"Mass spectrometry of amino acids and proteins","author":"Maleknia","year":"2012"},{"issue":"1","key":"10.1016\/j.jpba.2026.117555_bib34","doi-asserted-by":"crossref","first-page":"583","DOI":"10.1021\/acs.analchem.0c04342","article-title":"Native mass spectrometry of membrane proteins","volume":"93","author":"Keener","year":"2021","journal-title":"Anal. Chem."},{"issue":"1","key":"10.1016\/j.jpba.2026.117555_bib35","doi-asserted-by":"crossref","first-page":"4065","DOI":"10.1038\/s41467-020-17921-y","article-title":"Identification of modified peptides using localization-aware open search","volume":"11","author":"Yu","year":"2020","journal-title":"Nat. Commun."},{"key":"10.1016\/j.jpba.2026.117555_bib36","article-title":"Developing antibodies for detection of host cell protein contaminants","author":"Chimento","year":"2014","journal-title":"Gen. Eng. N."},{"key":"10.1016\/j.jpba.2026.117555_bib37","series-title":"Structural Approaches to Sequence Evolution: Molecules, Networks, Populations, Biological and Medical Physics, Biomedical Engineering","first-page":"207","article-title":"SeqinR 1.0-2: a contributed package to the R project for statistical computing devoted to biological sequences retrieval and analysis","author":"Charif","year":"2007"},{"key":"10.1016\/j.jpba.2026.117555_bib38","article-title":"OrgMassSpecR: Organic Mass Spectrometry","author":"Dodder","year":"2026","journal-title":"R. Package Version 0. 5-4"},{"issue":"1","key":"10.1016\/j.jpba.2026.117555_bib39","doi-asserted-by":"crossref","first-page":"4","DOI":"10.32614\/RJ-2015-001","article-title":"Peptides: a package for data mining of antimicrobial peptides","volume":"7","author":"Osorio","year":"2015","journal-title":"R. J."}],"container-title":["Journal of Pharmaceutical and Biomedical Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0731708526002232?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0731708526002232?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T11:46:14Z","timestamp":1783079174000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0731708526002232"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9]]},"references-count":39,"alternative-id":["S0731708526002232"],"URL":"https:\/\/doi.org\/10.1016\/j.jpba.2026.117555","relation":{},"ISSN":["0731-7085"],"issn-type":[{"value":"0731-7085","type":"print"}],"subject":[],"published":{"date-parts":[[2026,9]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Illuminating the Dark Host Cell Proteome: A host cell protein coverage method for LC-MS impurity assays","name":"articletitle","label":"Article Title"},{"value":"Journal of Pharmaceutical and Biomedical Analysis","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.jpba.2026.117555","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 The Author(s). Published by Elsevier B.V.","name":"copyright","label":"Copyright"}],"article-number":"117555"}}