{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,29]],"date-time":"2026-01-29T23:22:11Z","timestamp":1769728931576,"version":"3.49.0"},"reference-count":23,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2025,3,1]],"date-time":"2025-03-01T00:00:00Z","timestamp":1740787200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,3,1]],"date-time":"2025-03-01T00:00:00Z","timestamp":1740787200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2025,3,1]],"date-time":"2025-03-01T00:00:00Z","timestamp":1740787200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2025,3,1]],"date-time":"2025-03-01T00:00:00Z","timestamp":1740787200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2025,3,1]],"date-time":"2025-03-01T00:00:00Z","timestamp":1740787200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2025,3,1]],"date-time":"2025-03-01T00:00:00Z","timestamp":1740787200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2025,3,1]],"date-time":"2025-03-01T00:00:00Z","timestamp":1740787200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Pharmaceutical and Biomedical Analysis"],"published-print":{"date-parts":[[2025,3]]},"DOI":"10.1016\/j.jpba.2024.116633","type":"journal-article","created":{"date-parts":[[2024,12,11]],"date-time":"2024-12-11T02:55:36Z","timestamp":1733885736000},"page":"116633","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"special_numbering":"C","title":["Scaling analytical RP-HPLC to semi-preparative for fractionation and characterization of pegfilgrastim oxidized variants"],"prefix":"10.1016","volume":"255","author":[{"given":"Haley","family":"Sutton","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Teresa","family":"Youngberg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Perez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anke","family":"Hartung","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xuemei","family":"Han","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Navin","family":"Rauniyar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.jpba.2024.116633_bib1","unstructured":"Q6B Specifications: Test procedures and acceptance criteria for biotechnological\/biological products, 1999. (Accessed July 22, 2024). \u3008https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q6b-specifications-test-procedures-and-acceptance-criteria-biotechnologicalbiological-products\u3009."},{"key":"10.1016\/j.jpba.2024.116633_bib2","doi-asserted-by":"crossref","first-page":"1217","DOI":"10.1080\/19420862.2017.1368602","article-title":"Forced degradation of recombinant monoclonal antibodies: a practical guide","volume":"9","author":"Nowak","year":"2017","journal-title":"MAbs"},{"key":"10.1016\/j.jpba.2024.116633_bib3","doi-asserted-by":"crossref","first-page":"255","DOI":"10.2165\/00024669-200504040-00007","article-title":"Pegfilgrastim","volume":"4","author":"Frampton","year":"2005","journal-title":"Am. J. Cancer"},{"key":"10.1016\/j.jpba.2024.116633_bib4","doi-asserted-by":"crossref","first-page":"214","DOI":"10.1038\/nrd1033","article-title":"Effect of pegylation on pharmaceuticals","volume":"2","author":"Harris","year":"2003","journal-title":"Nat. Rev. Drug Discov."},{"key":"10.1016\/j.jpba.2024.116633_bib5","doi-asserted-by":"crossref","first-page":"1235","DOI":"10.2174\/1381612043452613","article-title":"The design and development of pegfilgrastim (PEG-rmetHuG-CSF, Neulasta)","volume":"10","author":"Molineux","year":"2004","journal-title":"Curr. Pharm. Des."},{"key":"10.1016\/j.jpba.2024.116633_bib6","doi-asserted-by":"crossref","first-page":"477","DOI":"10.1016\/S0169-409X(02)00023-6","article-title":"Mono-N-terminal poly(ethylene glycol)-protein conjugates","volume":"54","author":"Kinstler","year":"2002","journal-title":"Adv. Drug Deliv. Rev."},{"key":"10.1016\/j.jpba.2024.116633_bib7","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1155\/2012\/103973","article-title":"Poly(ethylene glycol)-Prodrug Conjugates: Concept, Design, and Applications","author":"Banerjee","year":"2012","journal-title":"J. Drug Deliv."},{"key":"10.1016\/j.jpba.2024.116633_bib8","doi-asserted-by":"crossref","first-page":"113","DOI":"10.1002\/biot.200900218","article-title":"PEGylation of therapeutic proteins","volume":"5","author":"Jev\u0161evar","year":"2010","journal-title":"Biotechnol. J."},{"key":"10.1016\/j.jpba.2024.116633_bib9","doi-asserted-by":"crossref","first-page":"3096","DOI":"10.1002\/jps.20207","article-title":"A comprehensive picture of non-site specific oxidation of methionine residues by peroxides in protein pharmaceuticals","volume":"93","author":"Chu","year":"2004","journal-title":"J. Pharm. Sci."},{"key":"10.1016\/j.jpba.2024.116633_bib10","doi-asserted-by":"crossref","first-page":"68","DOI":"10.1002\/prot.25995","article-title":"Modulation of granulocyte colony stimulating factor conformation and receptor binding by methionine oxidation","volume":"89","author":"Singh","year":"2021","journal-title":"Proteins"},{"key":"10.1016\/j.jpba.2024.116633_bib11","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1006\/abbi.1998.1022","article-title":"Chemical modification and site-directed mutagenesis of methionine residues in recombinant human granulocyte colony-stimulating factor: effect on stability and biological activity","volume":"362","author":"Lu","year":"1999","journal-title":"Arch. Biochem. Biophys."},{"key":"10.1016\/j.jpba.2024.116633_bib12","doi-asserted-by":"crossref","first-page":"141","DOI":"10.1007\/s11095-004-9019-x","article-title":"Effects of excipients on the hydrogen peroxide-induced oxidation of methionine residues in granulocyte colony-stimulating factor","volume":"22","author":"Yin","year":"2005","journal-title":"Pharm. Res."},{"key":"10.1016\/j.jpba.2024.116633_bib13","doi-asserted-by":"crossref","first-page":"1019","DOI":"10.1021\/bi0356000","article-title":"Molecular Dynamics Simulations and Oxidation Rates of Methionine Residues of Granulocyte Colony-Stimulating Factor at Different pH Values","volume":"43","author":"Chu","year":"2004","journal-title":"Biochemistry"},{"key":"10.1016\/j.jpba.2024.116633_bib14","doi-asserted-by":"crossref","first-page":"2408","DOI":"10.1021\/ac7020163","article-title":"Gas-phase proton-transfer chemistry coupled with TOF mass spectrometry and ion mobility-MS for the facile analysis of poly(ethylene glycols) and PEGylated polypeptide conjugates","volume":"80","author":"Bagal","year":"2008","journal-title":"Anal. Chem."},{"key":"10.1016\/j.jpba.2024.116633_bib15","doi-asserted-by":"crossref","first-page":"3081","DOI":"10.1039\/D4AY00660G","article-title":"Dimethyl sulfoxide as a gas phase charge-reducing agent for the determination of PEGylated proteins\u2019 intact mass","volume":"16","author":"Skj\u00e6rv\u00f8","year":"2024","journal-title":"Anal. Methods"},{"key":"10.1016\/j.jpba.2024.116633_bib16","doi-asserted-by":"crossref","first-page":"826","DOI":"10.1021\/ac403390y","article-title":"A direct-infusion- and HPLC-ESI-orbitrap-MS approach for the characterization of intact pegylated proteins","volume":"86","author":"Forstenlehner","year":"2014","journal-title":"Anal. Chem."},{"key":"10.1016\/j.jpba.2024.116633_bib17","doi-asserted-by":"crossref","first-page":"567","DOI":"10.1021\/ac801711u","article-title":"Characterization of poly(ethylene glycol) and PEGylated products by LC\/MS with postcolumn addition of amines","volume":"81","author":"Huang","year":"2009","journal-title":"Anal. Chem."},{"key":"10.1016\/j.jpba.2024.116633_bib18","doi-asserted-by":"crossref","first-page":"51","DOI":"10.1016\/S0021-9673(97)00715-2","article-title":"Temperature programming and gradient elution in reversed-phase chromatography with packed capillary columns","volume":"788","author":"Chen","year":"1997","journal-title":"J. Chromatogr. A"},{"key":"10.1016\/j.jpba.2024.116633_bib19","doi-asserted-by":"crossref","first-page":"810","DOI":"10.1016\/j.jasms.2010.01.011","article-title":"Elucidation of PEGylation site with a combined approach of in-source fragmentation and CID MS\/MS","volume":"21","author":"Lu","year":"2010","journal-title":"J. Am. Soc. Mass Spectrom."},{"key":"10.1016\/j.jpba.2024.116633_bib20","doi-asserted-by":"crossref","DOI":"10.1002\/jms.5017","article-title":"Characterization of PEGylation sites in Neulasta and a biosimilar candidate with a combined fragmentation strategy in mass spectrometry analysis","volume":"59","author":"Rauniyar","year":"2024","journal-title":"J. Mass Spectrom."},{"key":"10.1016\/j.jpba.2024.116633_bib21","doi-asserted-by":"crossref","first-page":"751","DOI":"10.1021\/pr0499646","article-title":"Statistical and mechanistic approaches to understanding the gas-phase fragmentation behavior of methionine sulfoxide containing peptides","volume":"3","author":"Reid","year":"2004","journal-title":"J. Proteome Res."},{"key":"10.1016\/j.jpba.2024.116633_bib22","doi-asserted-by":"crossref","first-page":"6667","DOI":"10.1007\/s00216-013-7138-0","article-title":"Top-down MS for rapid methionine oxidation site assignment in filgrastim","volume":"405","author":"Holzmann","year":"2013","journal-title":"Anal. Bioanal. Chem."},{"key":"10.1016\/j.jpba.2024.116633_bib23","doi-asserted-by":"crossref","first-page":"9336","DOI":"10.1021\/acs.analchem.5b02029","article-title":"Site-specific characterization and absolute quantification of pegfilgrastim oxidation by top-down high-performance liquid chromatography-mass spectrometry","volume":"87","author":"Forstenlehner","year":"2015","journal-title":"Anal. Chem."}],"container-title":["Journal of Pharmaceutical and Biomedical Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0731708524006757?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0731708524006757?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,1,29]],"date-time":"2026-01-29T12:18:58Z","timestamp":1769689138000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0731708524006757"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3]]},"references-count":23,"alternative-id":["S0731708524006757"],"URL":"https:\/\/doi.org\/10.1016\/j.jpba.2024.116633","relation":{},"ISSN":["0731-7085"],"issn-type":[{"value":"0731-7085","type":"print"}],"subject":[],"published":{"date-parts":[[2025,3]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Scaling analytical RP-HPLC to semi-preparative for fractionation and characterization of pegfilgrastim oxidized variants","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.2024.116633","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2024 Elsevier B.V. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}],"article-number":"116633"}}