{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T17:35:18Z","timestamp":1786988118217,"version":"build-2736575974"},"reference-count":37,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2018,9,1]],"date-time":"2018-09-01T00:00:00Z","timestamp":1535760000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2018,9,1]],"date-time":"2018-09-01T00:00:00Z","timestamp":1535760000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2018,6,14]],"date-time":"2018-06-14T00:00:00Z","timestamp":1528934400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Federal Institute for Drugs and Medical Devices"}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["European Journal of Pharmaceutics and Biopharmaceutics"],"published-print":{"date-parts":[[2018,9]]},"DOI":"10.1016\/j.ejpb.2018.06.009","type":"journal-article","created":{"date-parts":[[2018,6,9]],"date-time":"2018-06-09T10:47:33Z","timestamp":1528541253000},"page":"22-29","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":23,"special_numbering":"C","title":["Impact of extractables from rubber closures on protein stability under heat stress"],"prefix":"10.1016","volume":"130","author":[{"given":"Carolin","family":"Richter","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cornelia","family":"Lipperheide","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Uwe","family":"Lipke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alf","family":"Lamprecht","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.ejpb.2018.06.009_b0005","doi-asserted-by":"crossref","first-page":"33","DOI":"10.1186\/s12934-016-0437-3","article-title":"Recombinant pharmaceuticals from microbial cells: a 2015 update","volume":"15","author":"Sanchez-Garcia","year":"2016","journal-title":"Microb. Cell Fact."},{"issue":"4","key":"10.1016\/j.ejpb.2018.06.009_b0010","first-page":"307","article-title":"The development of stable protein formulations: a close look at protein aggregation, deamidation, and oxidation","volume":"10","author":"Cleland","year":"1993","journal-title":"Crit. Rev. Ther. Drug Carrier Syst."},{"issue":"3","key":"10.1016\/j.ejpb.2018.06.009_b0015","doi-asserted-by":"crossref","first-page":"501","DOI":"10.1208\/aapsj080359","article-title":"Effects of protein aggregates: an immunologic perspective","volume":"8","author":"Rosenberg","year":"2006","journal-title":"AAPS J."},{"issue":"9","key":"10.1016\/j.ejpb.2018.06.009_b0020","doi-asserted-by":"crossref","first-page":"3247","DOI":"10.1002\/jps.21834","article-title":"Immunogenicity of aggregates of recombinant human growth hormone in mouse models","volume":"98","author":"Fradkin","year":"2009","journal-title":"J. Pharm. Sci."},{"issue":"6","key":"10.1016\/j.ejpb.2018.06.009_b0025","doi-asserted-by":"crossref","first-page":"2055","DOI":"10.1002\/jps.23091","article-title":"Native-like aggregates of factor VIII are immunogenic in von Willebrand factor deficient and hemophilia a mice","volume":"101","author":"Pisal","year":"2012","journal-title":"J. Pharm. Sci."},{"key":"10.1016\/j.ejpb.2018.06.009_b0030","doi-asserted-by":"crossref","first-page":"187","DOI":"10.1002\/jps.22744","article-title":"Immunogenicity of recombinant human interferon beta interacting with particles of glass, metal, and polystyrene","volume":"101","author":"Van Beers","year":"2012","journal-title":"J. Pharm. Sci."},{"key":"10.1016\/j.ejpb.2018.06.009_b0035","series-title":"Pharmaceutical formulation development of peptides and proteins","article-title":"Peptides and proteins as parenteral solutions","author":"Akers","year":"2013"},{"key":"10.1016\/j.ejpb.2018.06.009_b0040","first-page":"1050","article-title":"Elastomeric components for the pharmaceutical industry","author":"Smith","year":"2002","journal-title":"Encyclop. Pharm. Technol."},{"issue":"6","key":"10.1016\/j.ejpb.2018.06.009_b0045","first-page":"1","article-title":"Standardized extractables testing protocol for single-use systems in biomanufacturing","volume":"34","author":"Ding","year":"2014","journal-title":"Pharm. Eng."},{"key":"10.1016\/j.ejpb.2018.06.009_b0050","doi-asserted-by":"crossref","first-page":"2209","DOI":"10.1002\/jps.22012","article-title":"On developing a process for conducting extractable-leachable assessment of components used for storage of biopharmaceuticals","volume":"99","author":"Wakankar","year":"2010","journal-title":"J. Pharm. Sci."},{"key":"10.1016\/j.ejpb.2018.06.009_b0055","first-page":"26","article-title":"A study of leachables for biopharmaceutical formulations stored in rubber-stoppered glass vials","volume":"23","author":"Decou","year":"2010","journal-title":"Biopharm. Int."},{"key":"10.1016\/j.ejpb.2018.06.009_b0060","unstructured":"Guideline on plastic immediate packaging materials, EMEA, 2005."},{"key":"10.1016\/j.ejpb.2018.06.009_b0065","unstructured":"Nasal spray and inhalation solution, suspension, and spray drug products, Guidance for Industry, 2002."},{"key":"10.1016\/j.ejpb.2018.06.009_b0070","unstructured":"Container closure systems for packaging human drugs and biologics, Guidance for Industry, 1999."},{"key":"10.1016\/j.ejpb.2018.06.009_b0075","unstructured":"Metered dose inhaler (MDI) and dry powder inhaler (DPI) drug products (Draft), Guidance for Industry, 1998."},{"key":"10.1016\/j.ejpb.2018.06.009_b0080","unstructured":"Rubber closures for containers for aqueous parenteral preparations, for powders and freeze-dried powders, in Ph. Eur. 3.2.9, current version."},{"key":"10.1016\/j.ejpb.2018.06.009_b0085","unstructured":"Elastomeric closures for injections, in USP <381>, current version."},{"issue":"4","key":"10.1016\/j.ejpb.2018.06.009_b0090","doi-asserted-by":"crossref","first-page":"727","DOI":"10.1007\/s11095-007-9521-z","article-title":"Best practices for extractables and leachables in orally inhaled and nasal drug products: An overview of the PQRI recommendations","volume":"25","author":"Norwood","year":"2008","journal-title":"Pharm. Res."},{"issue":"12","key":"10.1016\/j.ejpb.2018.06.009_b0095","doi-asserted-by":"crossref","first-page":"4419","DOI":"10.1002\/jps.23318","article-title":"Excipient effects on humanized monoclonal antibody interactions with silicone oil emulsions","volume":"101","author":"Britt","year":"2012","journal-title":"J. Pharm. Sci."},{"issue":"6","key":"10.1016\/j.ejpb.2018.06.009_b0100","doi-asserted-by":"crossref","first-page":"1454","DOI":"10.1007\/s11095-011-0621-4","article-title":"Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity","volume":"29","author":"Seidl","year":"2012","journal-title":"Pharm. Res."},{"key":"10.1016\/j.ejpb.2018.06.009_b0105","doi-asserted-by":"crossref","first-page":"318","DOI":"10.1016\/j.biotechadv.2007.01.006","article-title":"Immunogenicity of therapeutic proteins. Part 2: impact of container closures","volume":"25","author":"Sharma","year":"2007","journal-title":"Biotechnol. Adv."},{"issue":"7","key":"10.1016\/j.ejpb.2018.06.009_b0110","doi-asserted-by":"crossref","first-page":"1186","DOI":"10.1007\/s11095-005-5356-7","article-title":"Interaction of polysorbate 80 with erythropoietin: a case study in protein-surfactant interactions","volume":"22","author":"Villalobos","year":"2005","journal-title":"Pharm. Res."},{"issue":"6","key":"10.1016\/j.ejpb.2018.06.009_b0115","doi-asserted-by":"crossref","first-page":"2346","DOI":"10.1111\/j.1523-1755.2005.00340.x","article-title":"The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes","volume":"67","author":"Boven","year":"2005","journal-title":"Kidney Int."},{"issue":"11","key":"10.1016\/j.ejpb.2018.06.009_b0120","doi-asserted-by":"crossref","first-page":"4617","DOI":"10.1002\/jps.22670","article-title":"Impact of extractables\/leachables from filters on stability of protein formulations","volume":"100","author":"Huang","year":"2011","journal-title":"J. Pharm. Sci."},{"issue":"6","key":"10.1016\/j.ejpb.2018.06.009_b0125","doi-asserted-by":"crossref","first-page":"359","DOI":"10.1007\/BF02663750","article-title":"HPLC analysis of phenolic antioxidants, tocopherols, and triglycerides","volume":"68","author":"Andrikopoulos","year":"1991","journal-title":"JAOCS"},{"key":"10.1016\/j.ejpb.2018.06.009_b0130","unstructured":"Human normal immunoglobulin, in Ph. Eur., current version."},{"issue":"11","key":"10.1016\/j.ejpb.2018.06.009_b0135","doi-asserted-by":"crossref","first-page":"1360","DOI":"10.1023\/A:1015888704365","article-title":"Effect of freezing on aggregation of human growth hormone","volume":"8","author":"Eckhardt","year":"1991","journal-title":"Pharm. Res."},{"key":"10.1016\/j.ejpb.2018.06.009_b0140","unstructured":"Clarity and degree of opalescence of liquids, in Ph. Eur., current version."},{"key":"10.1016\/j.ejpb.2018.06.009_b0145","unstructured":"Erythropoetin concentrated solution, in Ph. Eur., current version."},{"key":"10.1016\/j.ejpb.2018.06.009_b0150","doi-asserted-by":"crossref","first-page":"91","DOI":"10.1016\/j.ijpharm.2008.04.020","article-title":"Determination of tris(2-ethylhexyl)trimellitate released from PVC tube by LC-MS\/MS","volume":"360","author":"Ito","year":"2008","journal-title":"Int. J. Pharm."},{"key":"10.1016\/j.ejpb.2018.06.009_b0155","unstructured":"EU risk assessment report bis(2-ethylhexyl)phtalate (DEHP), European Chemicals Bureau, 2008."},{"key":"10.1016\/j.ejpb.2018.06.009_b0160","unstructured":"EU risk assessment report dibutyl phtalate (DBP), European Chemicals Bureau, 2004."},{"key":"10.1016\/j.ejpb.2018.06.009_b0165","unstructured":"EU risk assessment report benzyl butyl phtalate (BBP), European Chemicals Bureau, 2007."},{"key":"10.1016\/j.ejpb.2018.06.009_b0170","unstructured":"The safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups possibly at risk (2015 update), Scientific Committee on Emerging and Newly-Identified Health Risks, 2015."},{"issue":"4","key":"10.1016\/j.ejpb.2018.06.009_b0175","doi-asserted-by":"crossref","first-page":"544","DOI":"10.1007\/s11095-009-0045-6","article-title":"Stability of protein pharmaceuticals: an update","volume":"27","author":"Manning","year":"2010","journal-title":"Pharm. Res."},{"key":"10.1016\/j.ejpb.2018.06.009_b0180","series-title":"Pharmaceutical formulation development of peptides and proteins","article-title":"Physical instability of peptides and proteins","author":"van de Weert","year":"2013"},{"key":"10.1016\/j.ejpb.2018.06.009_b0185","doi-asserted-by":"crossref","first-page":"136","DOI":"10.1002\/jps.2600630136","article-title":"CMC of polysorbate","volume":"63","author":"Wan","year":"1974","journal-title":"J. Pharm. Sci."}],"container-title":["European Journal of Pharmaceutics and Biopharmaceutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S093964111830256X?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S093964111830256X?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,10,15]],"date-time":"2025-10-15T16:30:58Z","timestamp":1760545858000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S093964111830256X"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,9]]},"references-count":37,"alternative-id":["S093964111830256X"],"URL":"https:\/\/doi.org\/10.1016\/j.ejpb.2018.06.009","relation":{},"ISSN":["0939-6411"],"issn-type":[{"value":"0939-6411","type":"print"}],"subject":[],"published":{"date-parts":[[2018,9]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Impact of extractables from rubber closures on protein stability under heat stress","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.2018.06.009","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2018 The Authors. Published by Elsevier B.V.","name":"copyright","label":"Copyright"}]}}