{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,21]],"date-time":"2025-09-21T09:24:39Z","timestamp":1758446679089,"version":"3.44.0"},"reference-count":49,"publisher":"Elsevier BV","issue":"11","license":[{"start":{"date-parts":[[2023,11,1]],"date-time":"2023-11-01T00:00:00Z","timestamp":1698796800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2023,11,1]],"date-time":"2023-11-01T00:00:00Z","timestamp":1698796800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"funder":[{"DOI":"10.13039\/100004334","name":"Merck &amp; Co Inc","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004334","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["jpharmsci.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Pharmaceutical Sciences"],"published-print":{"date-parts":[[2023,11]]},"DOI":"10.1016\/j.xphs.2023.07.013","type":"journal-article","created":{"date-parts":[[2023,7,20]],"date-time":"2023-07-20T02:05:06Z","timestamp":1689818706000},"page":"2778-2782","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"title":["Automated High-Throughput Matrix Assisted Laser Desorption Ionization Mass Spectrometry Methodology for Formulation Assessment of Polyethylene-Glycol-Conjugated Cytokine Proteins"],"prefix":"10.1016","volume":"112","author":[{"given":"Gregory F.","family":"Pirrone","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8024-9073","authenticated-orcid":false,"given":"Erik V.","family":"Munsell","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7126-3009","authenticated-orcid":false,"given":"Heidi M.","family":"Ferguson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mohammad A.","family":"Al-Sayah","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9310-3997","authenticated-orcid":false,"given":"Suman A.","family":"Luthra","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4866-0430","authenticated-orcid":false,"given":"Alexey A.","family":"Makarov","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"issue":"3","key":"10.1016\/j.xphs.2023.07.013_bib0001","doi-asserted-by":"crossref","first-page":"379","DOI":"10.1016\/j.drudis.2015.10.002","article-title":"The changing model of big pharma: impact of key trends","volume":"21","author":"Gautam","year":"2016","journal-title":"Drug Discov Today"},{"issue":"1","key":"10.1016\/j.xphs.2023.07.013_bib0002","doi-asserted-by":"crossref","first-page":"136","DOI":"10.1111\/cbdd.12055","article-title":"The future of peptide-based drugs","volume":"81","author":"Craik","year":"2013","journal-title":"Chem Biol Drug Des"},{"issue":"12","key":"10.1016\/j.xphs.2023.07.013_bib0003","doi-asserted-by":"crossref","first-page":"993","DOI":"10.1016\/j.tips.2016.10.005","article-title":"Emerging strategies for developing next-generation protein therapeutics for cancer treatment","volume":"37","author":"Kintzing","year":"2016","journal-title":"Trends Pharmacol Sci"},{"issue":"9","key":"10.1016\/j.xphs.2023.07.013_bib0004","doi-asserted-by":"crossref","first-page":"1257","DOI":"10.1080\/17425247.2016.1182485","article-title":"Polyethylene glycol (PEG): a versatile polymer for pharmaceutical applications","volume":"13","author":"D'souza","year":"2016","journal-title":"Expert Opin Drug Deliv"},{"key":"10.1016\/j.xphs.2023.07.013_bib0005","doi-asserted-by":"crossref","DOI":"10.1002\/anie.202203784","article-title":"Atomic-scale view of protein\u2013PEG interactions that redirect the thermal unfolding pathway of PEGylated human galectin-3","volume":"61","author":"Pritzlaff","year":"2022","journal-title":"Angew Chem Int Ed"},{"issue":"1","key":"10.1016\/j.xphs.2023.07.013_bib0006","doi-asserted-by":"crossref","first-page":"6","DOI":"10.1038\/s41416-018-0328-y","article-title":"Cytokines in clinical cancer immunotherapy","volume":"120","author":"Berraondo","year":"2019","journal-title":"Br J Cancer"},{"key":"10.1016\/j.xphs.2023.07.013_bib0007","doi-asserted-by":"crossref","DOI":"10.1016\/j.addr.2022.114112","article-title":"Engineering interferons and interleukins for cancer immunotherapy","volume":"182","author":"Holder","year":"2022","journal-title":"Adv Drug Deliv Rev"},{"key":"10.1016\/j.xphs.2023.07.013_bib0008","doi-asserted-by":"crossref","unstructured":"Warne N, Mahler, HC, Challenges in protein product development. 2018.","DOI":"10.1007\/978-3-319-90603-4"},{"issue":"4","key":"10.1016\/j.xphs.2023.07.013_bib0009","doi-asserted-by":"crossref","first-page":"468","DOI":"10.1177\/1087057114565593","article-title":"Accelerated formulation development of monoclonal antibodies (mAbs) and mAb-based modalities: review of methods and tools","volume":"20","author":"Razinkov","year":"2015","journal-title":"J Biomol Screen"},{"issue":"4","key":"10.1016\/j.xphs.2023.07.013_bib0010","doi-asserted-by":"crossref","first-page":"696","DOI":"10.1021\/mp200404c","article-title":"Advancements in high throughput biophysical technologies: applications for characterization and screening during early formulation development of monoclonal antibodies","volume":"9","author":"Samra","year":"2012","journal-title":"Mol Pharm"},{"key":"10.1016\/j.xphs.2023.07.013_bib0011","doi-asserted-by":"crossref","DOI":"10.1016\/j.ijpharm.2019.118505","article-title":"Science and art of protein formulation development","volume":"568","author":"Wang","year":"2019","journal-title":"Int J Pharm"},{"key":"10.1016\/j.xphs.2023.07.013_bib0012","first-page":"7853","article-title":"Matrix-assisted ultraviolet laser desorption of non-volatile compounds","author":"Karas","year":"1987","journal-title":"Int J Mass Spectrom Ion Process"},{"issue":"12","key":"10.1016\/j.xphs.2023.07.013_bib0013","doi-asserted-by":"crossref","first-page":"599","DOI":"10.1021\/a1960021u","article-title":"Mass spectrometry","volume":"68","author":"Burlingame","year":"1996","journal-title":"Anal Chem"},{"issue":"4","key":"10.1016\/j.xphs.2023.07.013_bib0014","doi-asserted-by":"crossref","first-page":"372","DOI":"10.1177\/2472555219880185","article-title":"MALDI-TOF mass spectrometry-based high-throughput screening for inhibitors of the cytosolic DNA sensor cGAS","volume":"25","author":"Simon","year":"2020","journal-title":"SLAS DISCOV: Adv Sci Drug Discov"},{"issue":"1","key":"10.1016\/j.xphs.2023.07.013_bib0015","doi-asserted-by":"crossref","first-page":"44","DOI":"10.1177\/2472555220959266","article-title":"MALDI-TOF-based affinity selection mass spectrometry for automated screening of protein\u2013ligand interactions at high throughput","volume":"26","author":"Simon","year":"2021","journal-title":"SLAS DISCOV: Adv Sci Drug Discov"},{"issue":"25","key":"10.1016\/j.xphs.2023.07.013_bib0016","doi-asserted-by":"crossref","first-page":"14705","DOI":"10.1073\/pnas.95.25.14705","article-title":"Identification of protein-protein interfaces by decreased amide proton solvent accessibility","volume":"95","author":"Mandell","year":"1998","journal-title":"Proc Natl Acad Sci"},{"issue":"19","key":"10.1016\/j.xphs.2023.07.013_bib0017","doi-asserted-by":"crossref","first-page":"3987","DOI":"10.1021\/ac980553g","article-title":"Measurement of amide hydrogen exchange by MALDI-TOF mass spectrometry","volume":"70","author":"Mandell","year":"1998","journal-title":"Anal Chem"},{"issue":"1","key":"10.1016\/j.xphs.2023.07.013_bib0018","doi-asserted-by":"crossref","first-page":"87","DOI":"10.1016\/j.abb.2011.05.009","article-title":"Role of calcium in the conformational dynamics of factor XIII activation examined by hydrogen-deuterium exchange coupled with MALDI-TOF MS","volume":"512","author":"Woofter","year":"2011","journal-title":"Arch Biochem Biophys"},{"issue":"16","key":"10.1016\/j.xphs.2023.07.013_bib0019","doi-asserted-by":"crossref","first-page":"8351","DOI":"10.1021\/acs.analchem.7b01590","article-title":"Use of MALDI-MS combined with differential hydrogen-deuterium exchange for semiautomated protein global conformational screening","volume":"89","author":"Pirrone","year":"2017","journal-title":"Anal Chem"},{"key":"10.1016\/j.xphs.2023.07.013_bib0020","doi-asserted-by":"crossref","first-page":"1054114","DOI":"10.1016\/j.aca.2018.12.034","article-title":"Use of MALDI-MS with solid-state hydrogen deuterium exchange for semi-automated assessment of peptide and protein physical stability in lyophilized solids","volume":"1054","author":"Kabaria","year":"2019","journal-title":"Anal Chim Acta"},{"key":"10.1016\/j.xphs.2023.07.013_bib0021","doi-asserted-by":"crossref","first-page":"1099111","DOI":"10.1016\/j.aca.2019.09.063","article-title":"Liposome artificial membrane permeability assay by MALDI-hydrogen-deuterium exchange mass spectrometry for peptides and small proteins","volume":"1099","author":"Makarov","year":"2020","journal-title":"Anal Chim Acta"},{"key":"10.1016\/j.xphs.2023.07.013_bib0022","doi-asserted-by":"crossref","DOI":"10.1016\/j.aca.2022.340234","article-title":"Rapid label-free cell-based approach membrane permeability assay using MALDI-hydrogen-deuterium exchange mass spectrometry for peptides","author":"Makarov","year":"2022","journal-title":"Anal Chim Acta"},{"issue":"12","key":"10.1016\/j.xphs.2023.07.013_bib0023","doi-asserted-by":"crossref","first-page":"2055","DOI":"10.1002\/jssc.202100986","article-title":"Rapid antibody conformational screening by matrix-assisted laser desorption\/ionization hydrogen-deuterium exchange mass spectrometry","volume":"45","author":"Mukherjee","year":"2022","journal-title":"J Sep Sci"},{"key":"10.1016\/j.xphs.2023.07.013_bib0024","first-page":"8611","article-title":"Forced degradation and impurity profiling: recent trends in analytical perspectives","author":"Jain","year":"2013","journal-title":"J Pharm Biomed Anal"},{"issue":"1","key":"10.1016\/j.xphs.2023.07.013_bib0025","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1080\/10408347.2016.1169913","article-title":"Development of impurity profiling methods using modern analytical techniques","volume":"47","author":"Ramachandra","year":"2017","journal-title":"Crit Rev Anal Chem"},{"issue":"8","key":"10.1016\/j.xphs.2023.07.013_bib0026","doi-asserted-by":"crossref","first-page":"1064","DOI":"10.2174\/1573411016999200612100927","article-title":"Modern analytical techniques for drug delivery systems characterization","volume":"17","author":"Rus","year":"2021","journal-title":"Curr Anal Chem"},{"issue":"20","key":"10.1016\/j.xphs.2023.07.013_bib0027","doi-asserted-by":"crossref","first-page":"2986","DOI":"10.1002\/elps.201400276","article-title":"Analysis of monoclonal antibody by a novel CE-UV\/MALDI-MS interface","volume":"35","author":"Biacchi","year":"2014","journal-title":"Electrophoresis"},{"issue":"7","key":"10.1016\/j.xphs.2023.07.013_bib0028","doi-asserted-by":"crossref","first-page":"754","DOI":"10.1139\/cjc-2015-0061","article-title":"An integrated approach to analyze EG2-hFc monoclonal antibody N-glycosylation by MALDI-MS","volume":"93","author":"Bodnar","year":"2015","journal-title":"Can J Chem"},{"key":"10.1016\/j.xphs.2023.07.013_bib0029","first-page":"115121","article-title":"MALDI-MS for polymer characterization -recent developments and future prospects","author":"Drzezdzon","year":"2019","journal-title":"Trac-Trend Anal Chem"},{"key":"10.1016\/j.xphs.2023.07.013_bib0030","doi-asserted-by":"crossref","DOI":"10.1016\/j.trac.2021.116328","article-title":"Mass spectrometry analytical responses to the SARS-CoV2 coronavirus in review","author":"Griffin","year":"2021","journal-title":"Trends Analyt Chem"},{"key":"10.1016\/j.xphs.2023.07.013_bib0031","first-page":"146405","article-title":"Sample preparation techniques for peptides and proteins analyzed by MALDI-MS","author":"Kussmann","year":"2000","journal-title":"Methods Mol Biol"},{"issue":"7","key":"10.1016\/j.xphs.2023.07.013_bib0032","doi-asserted-by":"crossref","first-page":"1174","DOI":"10.1007\/s13361-019-02213-7","article-title":"Effects of matrices and additives on multiple charge formation of proteins in MALDI-MS analysis","volume":"30","author":"Choi","year":"2019","journal-title":"J Am Soc Mass Spectrom"},{"issue":"4","key":"10.1016\/j.xphs.2023.07.013_bib0033","doi-asserted-by":"crossref","first-page":"1687","DOI":"10.1016\/j.xphs.2020.10.036","article-title":"In-use interfacial stability of monoclonal antibody formulations diluted in saline i.v. bags","volume":"110","author":"Kannan","year":"2021","journal-title":"J Pharm Sci"},{"issue":"Pt B","key":"10.1016\/j.xphs.2023.07.013_bib0034","doi-asserted-by":"crossref","first-page":"1692","DOI":"10.1016\/j.ijbiomac.2017.10.034","article-title":"The effects of allantoin, arginine and NaCl on thermal melting and aggregation of ribonuclease, bovine serum albumin and lysozyme","volume":"107","author":"Arakawa","year":"2018","journal-title":"Int J Biol Macromol"},{"issue":"13","key":"10.1016\/j.xphs.2023.07.013_bib0035","doi-asserted-by":"crossref","first-page":"1118","DOI":"10.1016\/j.addr.2011.07.006","article-title":"Protein-excipient interactions: mechanisms and biophysical characterization applied to protein formulation development","volume":"63","author":"Kamerzell","year":"2011","journal-title":"Adv Drug Deliv Rev"},{"issue":"7","key":"10.1016\/j.xphs.2023.07.013_bib0036","doi-asserted-by":"crossref","first-page":"3965","DOI":"10.1021\/acs.chemrev.8b00006","article-title":"Designing smart polymer conjugates for controlled release of payloads","volume":"118","author":"Seidi","year":"2018","journal-title":"Chem Rev"},{"issue":"9","key":"10.1016\/j.xphs.2023.07.013_bib0037","doi-asserted-by":"crossref","first-page":"3388","DOI":"10.1021\/cr5004634","article-title":"Mechanisms of drug release in nanotherapeutic delivery systems","volume":"115","author":"Wong","year":"2015","journal-title":"Chem Rev"},{"issue":"7","key":"10.1016\/j.xphs.2023.07.013_bib0038","doi-asserted-by":"crossref","first-page":"1743","DOI":"10.1021\/ja01468a044","article-title":"General base catalysis of ester hydrolysis","volume":"83","author":"Jencks","year":"1961","journal-title":"J Am Chem Soc"},{"issue":"9","key":"10.1016\/j.xphs.2023.07.013_bib0039","doi-asserted-by":"crossref","first-page":"3288","DOI":"10.1021\/acs.molpharmaceut.2c00453","article-title":"Understanding the stabilizing effect of histidine on mAb aggregation: a molecular dynamics study","volume":"19","author":"Saurabh","year":"2022","journal-title":"Mol Pharm"},{"issue":"3","key":"10.1016\/j.xphs.2023.07.013_bib0040","doi-asserted-by":"crossref","first-page":"276","DOI":"10.1039\/c2bm00140c","article-title":"Effect of sodium chloride on the structure and stability of spider silk's N-terminal protein domain","volume":"1","author":"Gronau","year":"2013","journal-title":"Biomater Sci"},{"issue":"1-12","key":"10.1016\/j.xphs.2023.07.013_bib0041","doi-asserted-by":"crossref","first-page":"555","DOI":"10.1007\/s12010-007-9079-6","article-title":"Evaluation of the pH- and thermal stability of the recombinant green fluorescent protein (GFP) in the presence of sodium chloride","volume":"137-140","author":"Ishii","year":"2007","journal-title":"Appl Biochem Biotechnol"},{"issue":"9","key":"10.1016\/j.xphs.2023.07.013_bib0042","doi-asserted-by":"crossref","first-page":"1290","DOI":"10.1177\/1087057114542431","article-title":"High-throughput screening and stability optimization of anti-streptavidin IgG1 and IgG2 formulations","volume":"19","author":"Alekseychyk","year":"2014","journal-title":"J Biomol Screen"},{"issue":"25","key":"10.1016\/j.xphs.2023.07.013_bib0043","doi-asserted-by":"crossref","first-page":"6536","DOI":"10.1021\/bi00268a033","article-title":"Stabilization of protein structure by sugars","volume":"21","author":"Arakawa","year":"1982","journal-title":"Biochemistry"},{"issue":"4","key":"10.1016\/j.xphs.2023.07.013_bib0044","doi-asserted-by":"crossref","first-page":"1707","DOI":"10.1002\/jps.21955","article-title":"High throughput thermostability screening of monoclonal antibody formulations","volume":"99","author":"He","year":"2010","journal-title":"J Pharm Sci"},{"issue":"7","key":"10.1016\/j.xphs.2023.07.013_bib0045","doi-asserted-by":"crossref","first-page":"2590","DOI":"10.1016\/j.xphs.2021.03.017","article-title":"A review of formulations of commercially available antibodies","volume":"110","author":"Strickley","year":"2021","journal-title":"J Pharm Sci"},{"issue":"1","key":"10.1016\/j.xphs.2023.07.013_bib0046","doi-asserted-by":"crossref","first-page":"224","DOI":"10.1021\/jf0204699","article-title":"Kinetics of hydrolysis of fructooligosaccharides in mineral-buffered aqueous solutions: influence of pH and temperature","volume":"51","author":"L'Homme","year":"2003","journal-title":"J Agric Food Chem"},{"key":"10.1016\/j.xphs.2023.07.013_bib0047","first-page":"327397","article-title":"Advancements in the co-formulation of biologic therapeutics","author":"Chauhan","year":"2020","journal-title":"J Control Rel"},{"issue":"5","key":"10.1016\/j.xphs.2023.07.013_bib0048","doi-asserted-by":"crossref","first-page":"666","DOI":"10.1111\/jphp.12731","article-title":"Challenges for the pharmaceutical technical development of protein coformulations","volume":"70","author":"Mueller","year":"2018","journal-title":"J Pharm Pharmacol"},{"key":"10.1016\/j.xphs.2023.07.013_bib0049","first-page":"617","article-title":"Targeting solid tumors with bispecific T cell engager immune therapy","author":"Arvedson","year":"2022","journal-title":"Annu Rev Canc Biol"}],"container-title":["Journal of Pharmaceutical Sciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0022354923002897?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0022354923002897?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,9,20]],"date-time":"2025-09-20T09:45:02Z","timestamp":1758361502000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0022354923002897"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,11]]},"references-count":49,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2023,11]]}},"alternative-id":["S0022354923002897"],"URL":"https:\/\/doi.org\/10.1016\/j.xphs.2023.07.013","relation":{},"ISSN":["0022-3549"],"issn-type":[{"type":"print","value":"0022-3549"}],"subject":[],"published":{"date-parts":[[2023,11]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Automated High-Throughput Matrix Assisted Laser Desorption Ionization Mass Spectrometry Methodology for Formulation Assessment of Polyethylene-Glycol-Conjugated Cytokine Proteins","name":"articletitle","label":"Article Title"},{"value":"Journal of Pharmaceutical Sciences","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.xphs.2023.07.013","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.","name":"copyright","label":"Copyright"}]}}