{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,9]],"date-time":"2026-01-09T13:09:02Z","timestamp":1767964142155,"version":"3.49.0"},"reference-count":21,"publisher":"Informa UK Limited","issue":"10","content-domain":{"domain":["www.tandfonline.com"],"crossmark-restriction":true},"short-container-title":["Bioanalysis"],"published-print":{"date-parts":[[2017,5]]},"DOI":"10.4155\/bio-2016-0274","type":"journal-article","created":{"date-parts":[[2017,4,28]],"date-time":"2017-04-28T16:27:59Z","timestamp":1493396879000},"page":"775-786","update-policy":"https:\/\/doi.org\/10.1080\/tandf_crossmark_01","source":"Crossref","is-referenced-by-count":2,"title":["A Comparison Study of Bioanalytical Methods for Detection and Characterization of Anti-Velaglucerase Alfa Antibodies"],"prefix":"10.1080","volume":"9","author":[{"given":"Diana R","family":"Najarian","sequence":"first","affiliation":[{"name":"Bioanalytical &amp; Biomarker Development, 300 Shire Way, Lexington, MA02421, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kelly","family":"Hilton","sequence":"additional","affiliation":[{"name":"Bioanalytical &amp; Biomarker Development, 300 Shire Way, Lexington, MA02421, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"McCauley","sequence":"additional","affiliation":[{"name":"Nonclinical Development, 300 Shire, Lexington, MA02421, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yongchang","family":"Qiu","sequence":"additional","affiliation":[{"name":"Bioanalytical &amp; Biomarker Development, 300 Shire Way, Lexington, MA02421, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"301","published-online":{"date-parts":[[2017,4,28]]},"reference":[{"key":"e_1_3_4_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0950-3536(97)80033-9"},{"key":"e_1_3_4_4_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.seminhematol.2004.07.009"},{"key":"e_1_3_4_5_1","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-015-9857-y"},{"key":"e_1_3_4_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cellimm.2015.03.002"},{"key":"e_1_3_4_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2012.363"},{"key":"e_1_3_4_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.34680"},{"key":"e_1_3_4_9_1","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-012-9340-y"},{"key":"e_1_3_4_10_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0047805"},{"key":"e_1_3_4_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ymgme.2012.04.027"},{"key":"e_1_3_4_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/GIM.0b013e3182174703"},{"key":"e_1_3_4_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ymgme.2008.10.004"},{"key":"e_1_3_4_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2008.03828.x"},{"key":"e_1_3_4_15_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa020888"},{"key":"e_1_3_4_16_1","first-page":"15","article-title":"Immunogenicity of biological therapeutics: a hierarchy of concerns","volume":"112","author":"Rosenberg AS","year":"2003","unstructured":"Rosenberg AS . Immunogenicity of biological therapeutics: a hierarchy of concerns. Dev. Biol (Basel)112, 15\u201321 (2003).","journal-title":"Dev. Biol (Basel)"},{"key":"e_1_3_4_17_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa011931"},{"key":"e_1_3_4_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0149-2918(02)80075-3"},{"key":"e_1_3_4_19_1","doi-asserted-by":"publisher","DOI":"10.1006\/mgme.1999.2894"},{"key":"e_1_3_4_20_1","volume-title":"Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products","year":"2014","unstructured":"Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products . Food and Drug Administration, Center for Drug Evaluation and Research (CDER), US Department of Health and Human Services (2014). www.fda.gov\/downloads\/drugs\/guidances\/ucm338856.pdf"},{"key":"e_1_3_4_21_1","volume-title":"Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins","year":"2007","unstructured":"Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins . European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). EMEA\/CHMP\/BMWP\/14327\/2006 (2007). www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2009\/09\/WC500003946.pdf"},{"key":"e_1_3_4_22_1","volume-title":"ICH Guideline S6 (R1) \u2013 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals","year":"2011","unstructured":"ICH Guideline S6 (R1) \u2013 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals . European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). EMA\/CHMP\/ICH\/731268\/1998 (2011). www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2009\/09\/WC500002828.pdf"},{"key":"e_1_3_4_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jim.2011.07.020"}],"container-title":["Bioanalysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.tandfonline.com\/doi\/pdf\/10.4155\/bio-2016-0274","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,17]],"date-time":"2024-05-17T14:54:23Z","timestamp":1715957663000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.tandfonline.com\/doi\/full\/10.4155\/bio-2016-0274"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,4,28]]},"references-count":21,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2017,5]]}},"alternative-id":["10.4155\/bio-2016-0274"],"URL":"https:\/\/doi.org\/10.4155\/bio-2016-0274","relation":{},"ISSN":["1757-6180","1757-6199"],"issn-type":[{"value":"1757-6180","type":"print"},{"value":"1757-6199","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,4,28]]},"assertion":[{"value":"The publishing and review policy for this title is described in its Aims & Scope.","order":1,"name":"peerreview_statement","label":"Peer Review Statement"},{"value":"http:\/\/www.tandfonline.com\/action\/journalInformation?show=aimsScope&journalCode=ibio20","URL":"http:\/\/www.tandfonline.com\/action\/journalInformation?show=aimsScope&journalCode=ibio20","order":2,"name":"aims_and_scope_url","label":"Aim & Scope"},{"value":"2016-10-24","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2017-03-29","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2017-04-28","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}