{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T10:16:42Z","timestamp":1779272202241,"version":"3.51.4"},"reference-count":36,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2022,9,1]],"date-time":"2022-09-01T00:00:00Z","timestamp":1661990400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2022,9,1]],"date-time":"2022-09-01T00:00:00Z","timestamp":1661990400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2022,9,1]],"date-time":"2022-09-01T00:00:00Z","timestamp":1661990400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2022,9,1]],"date-time":"2022-09-01T00:00:00Z","timestamp":1661990400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2022,9,1]],"date-time":"2022-09-01T00:00:00Z","timestamp":1661990400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2022,9,1]],"date-time":"2022-09-01T00:00:00Z","timestamp":1661990400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2022,9,1]],"date-time":"2022-09-01T00:00:00Z","timestamp":1661990400000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"funder":[{"DOI":"10.13039\/501100001412","name":"Council of Scientific and Industrial Research, India","doi-asserted-by":"publisher","award":["09\/086(1366)2019-EMR-I"],"award-info":[{"award-number":["09\/086(1366)2019-EMR-I"]}],"id":[{"id":"10.13039\/501100001412","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001407","name":"Department of Biotechnology Ministry of Science and Technology","doi-asserted-by":"publisher","award":["BT\/COE\/34\/SP15097\/2015"],"award-info":[{"award-number":["BT\/COE\/34\/SP15097\/2015"]}],"id":[{"id":"10.13039\/501100001407","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["European Journal of Pharmaceutics and Biopharmaceutics"],"published-print":{"date-parts":[[2022,9]]},"DOI":"10.1016\/j.ejpb.2022.08.002","type":"journal-article","created":{"date-parts":[[2022,8,10]],"date-time":"2022-08-10T12:37:33Z","timestamp":1660135053000},"page":"131-139","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":10,"special_numbering":"C","title":["Impact of various factors on the kinetics of non-enzymatic fragmentation of a monoclonal antibody"],"prefix":"10.1016","volume":"178","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1535-9684","authenticated-orcid":false,"given":"Surbhi","family":"Gupta","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kratika","family":"Upadhyay","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Sch\u00f6neich","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5913-4244","authenticated-orcid":false,"given":"Anurag S","family":"Rathore","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.ejpb.2022.08.002_b0005","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1016\/j.tibtech.2018.05.014","article-title":"The increasingly human and profitable monoclonal antibody market","volume":"37","author":"Grilo","year":"2019","journal-title":"Trends Biotechnol."},{"key":"10.1016\/j.ejpb.2022.08.002_b0010","doi-asserted-by":"crossref","first-page":"159","DOI":"10.1016\/j.copbio.2019.01.014","article-title":"Chemical and physical instabilities in manufacturing and storage of therapeutic proteins","volume":"60","author":"Krause","year":"2019","journal-title":"Curr. Opin. Biotechnol."},{"key":"10.1016\/j.ejpb.2022.08.002_b0015","doi-asserted-by":"crossref","first-page":"169","DOI":"10.1016\/j.xphs.2019.08.009","article-title":"Physicochemical stability of monoclonal antibodies: a review","volume":"109","author":"le Basle","year":"2020","journal-title":"J. Pharm. Sci."},{"key":"10.1016\/j.ejpb.2022.08.002_b0020","doi-asserted-by":"crossref","first-page":"253","DOI":"10.4161\/mabs.3.3.15608","article-title":"Fragmentation of monoclonal antibodies","volume":"3","author":"Vlasak","year":"2011","journal-title":"MAbs."},{"key":"10.1016\/j.ejpb.2022.08.002_b0025","doi-asserted-by":"crossref","first-page":"6976","DOI":"10.1021\/ja0705994","article-title":"\u03b2-elimination and peptide bond hydrolysis: two distinct mechanisms of human IgG1 hinge fragmentation upon storage","volume":"129","author":"Cohen","year":"2007","journal-title":"J. Am. Chem. Soc."},{"key":"10.1016\/j.ejpb.2022.08.002_b0030","doi-asserted-by":"crossref","first-page":"115","DOI":"10.1016\/j.jchromb.2004.12.033","article-title":"Non-enzymatic hinge region fragmentation of antibodies in solution","volume":"818","author":"Cordoba","year":"2005","journal-title":"J. Chromatogr. B"},{"key":"10.1016\/j.ejpb.2022.08.002_b0035","doi-asserted-by":"crossref","first-page":"254","DOI":"10.1016\/j.jchromb.2007.08.043","article-title":"Structural effect of a recombinant monoclonal antibody on hinge region peptide bond hydrolysis","volume":"858","author":"Xiang","year":"2007","journal-title":"J. Chromatogr. B"},{"key":"10.1016\/j.ejpb.2022.08.002_b0040","doi-asserted-by":"crossref","first-page":"48","DOI":"10.1111\/j.1399-3011.1996.tb01105.x","article-title":"Specific cleavage of immunoglobulin G by copper ions","volume":"48","author":"Smith","year":"1996","journal-title":"Int. J. Peptide Protein Res."},{"key":"10.1016\/j.ejpb.2022.08.002_b0045","doi-asserted-by":"crossref","first-page":"901","DOI":"10.1080\/19420862.2015.1062193","article-title":"Metal ion interactions with mAbs: Part 1 pH and conformation modulate copper-mediated site-specific fragmentation of the IgG1 hinge region","volume":"7","author":"Glover","year":"2015","journal-title":"MAbs."},{"key":"10.1016\/j.ejpb.2022.08.002_b0050","doi-asserted-by":"crossref","first-page":"24674","DOI":"10.1074\/jbc.M111.255026","article-title":"Breaking the light and heavy chain linkage of human immunoglobulin G1 (IgG1) by radical reactions","volume":"286","author":"Yan","year":"2011","journal-title":"J. Biol. Chem."},{"issue":"26","key":"10.1016\/j.ejpb.2022.08.002_b0055","doi-asserted-by":"crossref","first-page":"6105","DOI":"10.1021\/ja954077c","article-title":"Rates of uncatalyzed peptide bond hydrolysis in neutral solution and the transition state affinities of proteases","volume":"118","author":"Radzicka","year":"1996","journal-title":"J. Am. Chem. Soc."},{"key":"10.1016\/j.ejpb.2022.08.002_b0060","doi-asserted-by":"crossref","first-page":"1881","DOI":"10.1007\/s11095-008-9606-3","article-title":"Fragmentation of a recombinant monoclonal antibody at various pH","volume":"25","author":"Gaza-Bulseco","year":"2008","journal-title":"Pharm. Res."},{"key":"10.1016\/j.ejpb.2022.08.002_b0065","doi-asserted-by":"crossref","first-page":"1341","DOI":"10.1002\/jps.22389","article-title":"The relative rate of immunoglobulin gamma 1 fragmentation","volume":"100","author":"Kamerzell","year":"2011","journal-title":"J. Pharm. Sci."},{"key":"10.1016\/j.ejpb.2022.08.002_b0070","doi-asserted-by":"crossref","first-page":"35390","DOI":"10.1074\/jbc.M109.064147","article-title":"Human IgG1 Hinge Fragmentation as the Result of H2O2-mediated Radical Cleavage","volume":"284","author":"Yan","year":"2009","journal-title":"J. Biol. Chem."},{"issue":"20","key":"10.1016\/j.ejpb.2022.08.002_b0075","doi-asserted-by":"crossref","first-page":"10930","DOI":"10.1073\/pnas.97.20.10930","article-title":"Antibodies have the intrinsic capacity to destroy antigens","volume":"97","author":"Wentworth","year":"2000","journal-title":"Proc. Natl. Acad. Sci. U S A."},{"issue":"5","key":"10.1016\/j.ejpb.2022.08.002_b0080","doi-asserted-by":"crossref","first-page":"2636","DOI":"10.1073\/pnas.052709399","article-title":"Mechanism for antibody catalysis of the oxidation of water by singlet dioxygen","volume":"99","author":"Datta","year":"2002","journal-title":"Proc. Natl. Acad. Sci. U S A."},{"issue":"4","key":"10.1016\/j.ejpb.2022.08.002_b0085","doi-asserted-by":"crossref","first-page":"1490","DOI":"10.1073\/pnas.0437831100","article-title":"Evidence for the production of trioxygen species during antibody-catalyzed chemical modification of antigens","volume":"100","author":"Wentworth","year":"2003","journal-title":"Proc. Natl. Acad. Sci. U S A."},{"issue":"8","key":"10.1016\/j.ejpb.2022.08.002_b0090","doi-asserted-by":"crossref","first-page":"2247","DOI":"10.1073\/pnas.0307311101","article-title":"Probing the antibody-catalyzed water-oxidation pathway at atomic resolution","volume":"101","author":"Zhu","year":"2004","journal-title":"Proc. Natl. Acad. Sci. U S A."},{"key":"10.1016\/j.ejpb.2022.08.002_b0095","unstructured":"M. Bonifa\u00e1ic, K. Asmus, P. Capezzuto, F. Cramarossa, G. Ferraro, P. Maione, E. Molinari, J. Quant Spectrosc Radiat, M. Capitelli, E. Ficocelli, D.L. S Me Elwaln, M. Bonifacio, K. Schafer, H. M\u00f3ckel, Electronic and Ionic Impact Phenomena, McGraw-Hill, 1974. https:\/\/pubs.acs.org\/sharingguidelines."},{"key":"10.1016\/j.ejpb.2022.08.002_b0100","doi-asserted-by":"crossref","DOI":"10.3390\/molecules24234357","article-title":"Thiyl radical reactions in the chemical degradation of pharmaceutical proteins","volume":"24","author":"Sch\u00f6neich","year":"2019","journal-title":"Molecules"},{"key":"10.1016\/j.ejpb.2022.08.002_b0105","doi-asserted-by":"crossref","first-page":"107","DOI":"10.1016\/j.ab.2009.03.027","article-title":"Elevated cleavage of human immunoglobulin gamma molecules containing a lambda light chain mediated by iron and histidine","volume":"389","author":"Ouellette","year":"2009","journal-title":"Anal. Biochem."},{"key":"10.1016\/j.ejpb.2022.08.002_b0110","doi-asserted-by":"crossref","DOI":"10.1007\/s11095-018-2415-4","article-title":"Kinetics and characterization of non-enzymatic fragmentation of monoclonal antibody therapeutics","volume":"35","author":"Ravuluri","year":"2018","journal-title":"Pharm. Res."},{"key":"10.1016\/j.ejpb.2022.08.002_b0115","doi-asserted-by":"crossref","first-page":"1133","DOI":"10.1016\/S0731-7085(96)01721-9","article-title":"The effect of pH, hydrogen peroxide and temperature on the stability of human monoclonal antibody","volume":"14","author":"Usami","year":"1996","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.ejpb.2022.08.002_b0120","doi-asserted-by":"crossref","unstructured":"G. McDonnell, The Use of Hydrogen Peroxide for Disinfection and Sterilization Applications, in: PATAI\u2019S Chemistry of Functional Groups, John Wiley & Sons, Ltd, Chichester, UK, 2014: pp. 1\u201334. https:\/\/doi.org\/10.1002\/9780470682531.pat0885.","DOI":"10.1002\/9780470682531.pat0885"},{"issue":"1983","key":"10.1016\/j.ejpb.2022.08.002_b0125","first-page":"711","article-title":"Photochemical Formation of Hydrogen Peroxide in Surface and Ground Waters Exposed to Sunlight","volume":"220","author":"Cooper","year":"1979","journal-title":"Science"},{"key":"10.1016\/j.ejpb.2022.08.002_b0130","doi-asserted-by":"crossref","first-page":"325","DOI":"10.1146\/annurev.pharmtox.44.101802.121735","article-title":"Protein sulfenic acids in redox signaling","volume":"44","author":"Poole","year":"2004","journal-title":"Annu. Rev. Pharmacol. Toxicol."},{"issue":"14","key":"10.1016\/j.ejpb.2022.08.002_b0135","doi-asserted-by":"crossref","first-page":"5044","DOI":"10.1073\/pnas.0501154102","article-title":"Hydrogen peroxide generated extracellularly by receptor-ligand interaction facilitates cell signaling","volume":"102","author":"DeYulia","year":"2005","journal-title":"Proc. Natl. Acad. Sci."},{"key":"10.1016\/j.ejpb.2022.08.002_b0140","doi-asserted-by":"crossref","first-page":"106","DOI":"10.1002\/jps.20726","article-title":"Evaluation of Hydroperoxides in Common Pharmaceutical Excipients","volume":"96","author":"Wasylaschuk","year":"2007","journal-title":"J. Pharm. Sci."},{"key":"10.1016\/j.ejpb.2022.08.002_b0145","doi-asserted-by":"crossref","first-page":"1194","DOI":"10.1007\/s11095-011-0385-x","article-title":"The degradation of polysorbates 20 and 80 and its potential impact on the stability of biotherapeutics","volume":"28","author":"Kishore","year":"2011","journal-title":"Pharm. Res."},{"key":"10.1016\/j.ejpb.2022.08.002_b0150","doi-asserted-by":"crossref","first-page":"550","DOI":"10.1021\/bp0497029","article-title":"Effect of copper sulfate on performance of a serum-free CHO cell culture process and the level of free thiol in the recombinant antibody expressed","volume":"21","author":"Chaderjian","year":"2005","journal-title":"Biotechnol. Prog."},{"issue":"8","key":"10.1016\/j.ejpb.2022.08.002_b0155","doi-asserted-by":"crossref","first-page":"2000464","DOI":"10.1002\/biot.202000464","article-title":"Effect of vitamins and metal ions on productivity and charge heterogeneity of IgG1 expressed in CHO cells","volume":"16","author":"Gangwar","year":"2021","journal-title":"Biotechnol. J."},{"key":"10.1016\/j.ejpb.2022.08.002_b0160","doi-asserted-by":"crossref","first-page":"2962","DOI":"10.1002\/jps.22056","article-title":"Buffer-dependent fragmentation of a humanized full-length monoclonal antibody","volume":"99","author":"Salinas","year":"2010","journal-title":"J. Pharm. Sci."},{"key":"10.1016\/j.ejpb.2022.08.002_b0165","doi-asserted-by":"crossref","DOI":"10.1186\/s40543-022-00317-6","article-title":"Systematic strategies for degradation kinetic study of pharmaceuticals: an issue of utmost importance concerning current stability analysis practices","volume":"13","author":"Bhangare","year":"2022","journal-title":"J. Anal. Sci. Technol."},{"key":"10.1016\/j.ejpb.2022.08.002_b0170","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1007\/s11783-010-0251-9","article-title":"Kinetics of microwave-enhanced oxidation of phenol by hydrogen peroxide","volume":"5","author":"Zhao","year":"2011","journal-title":"Front. Environ. Sci. Eng. China"},{"key":"10.1016\/j.ejpb.2022.08.002_b0175","unstructured":"Ascorbate oxidation by iron, copper and reactive oxygen species: review, model development, and derivation of key rate constants | Enhanced Reader, (n.d.)."},{"issue":"9","key":"10.1016\/j.ejpb.2022.08.002_b0180","doi-asserted-by":"crossref","first-page":"1602","DOI":"10.3390\/ijerph16091602","article-title":"Kinetic evaluation of dye decolorization by fenton processes in the presence of 3-hydroxyanthranilic acid","volume":"16","author":"Sidney Santana","year":"2019","journal-title":"Int. J. Environ. Res. Public Health"}],"container-title":["European Journal of Pharmaceutics and Biopharmaceutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0939641122001680?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0939641122001680?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,5,14]],"date-time":"2026-05-14T16:27:17Z","timestamp":1778776037000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0939641122001680"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,9]]},"references-count":36,"alternative-id":["S0939641122001680"],"URL":"https:\/\/doi.org\/10.1016\/j.ejpb.2022.08.002","relation":{},"ISSN":["0939-6411"],"issn-type":[{"value":"0939-6411","type":"print"}],"subject":[],"published":{"date-parts":[[2022,9]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Impact of various factors on the kinetics of non-enzymatic fragmentation of a monoclonal antibody","name":"articletitle","label":"Article Title"},{"value":"European Journal of Pharmaceutics and Biopharmaceutics","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.ejpb.2022.08.002","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2022 Elsevier B.V. All rights reserved.","name":"copyright","label":"Copyright"}]}}