Validation of Monosaccharide Composition Assay Using HPLC-UV Platform for Monoclonal Antibody Products in Compliance with ICH Guideline
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Kwon, Ohseok | - |
dc.contributor.author | Oh, Il Ung | - |
dc.contributor.author | Oh, Myung Jin | - |
dc.contributor.author | Hong, Seung Hwa | - |
dc.contributor.author | Kim, Chan Wha | - |
dc.contributor.author | An, Hyun Joo | - |
dc.date.accessioned | 2021-09-02T02:30:41Z | - |
dc.date.available | 2021-09-02T02:30:41Z | - |
dc.date.created | 2021-06-19 | - |
dc.date.issued | 2018-12 | - |
dc.identifier.issn | 0253-2964 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/71368 | - |
dc.description.abstract | Monoclonal antibodies (mAbs) are the largest class of glycosylated biopharmaceuticals. Glycans are a key functional component of mAbs, and thus their characterization is highly required during mAb developmental and regulatory phases. In particular, monosaccharides are crucial for antibody efficacy, safety, cytotoxicity, and potency, so reliable monosaccharide composition assay (MCA) is required for quality control (QC) testing. Traditional methods for MCA such as HPAE-PAD and HPLC-FLD have been suffering from low sensitivity and poor reproducibility. In this study, we developed an alternative QC method for MCA of mAb with 1-Phenyl-3-methyl-5-pyrazolone (PMP) tag products using HPLC-UV platform equipped in most QC laboratories. Four characteristics including specificity, linearity, precision, and accuracy were systemically evaluated according to ICH Q2(R1) guideline. Inter-laboratory studies were also performed to validate method reproducibility and reliability. It will be a powerful platform for QC test of not only mAb products but also Fc fusion glycoprotein products. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | WILEY-V C H VERLAG GMBH | - |
dc.subject | BIOSIMILARS | - |
dc.title | Validation of Monosaccharide Composition Assay Using HPLC-UV Platform for Monoclonal Antibody Products in Compliance with ICH Guideline | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, Chan Wha | - |
dc.identifier.doi | 10.1002/bkcs.11612 | - |
dc.identifier.scopusid | 2-s2.0-85058636086 | - |
dc.identifier.wosid | 000453572000009 | - |
dc.identifier.bibliographicCitation | BULLETIN OF THE KOREAN CHEMICAL SOCIETY, v.39, no.12, pp.1394 - 1399 | - |
dc.relation.isPartOf | BULLETIN OF THE KOREAN CHEMICAL SOCIETY | - |
dc.citation.title | BULLETIN OF THE KOREAN CHEMICAL SOCIETY | - |
dc.citation.volume | 39 | - |
dc.citation.number | 12 | - |
dc.citation.startPage | 1394 | - |
dc.citation.endPage | 1399 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.identifier.kciid | ART002413513 | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.description.journalRegisteredClass | kci | - |
dc.relation.journalResearchArea | Chemistry | - |
dc.relation.journalWebOfScienceCategory | Chemistry, Multidisciplinary | - |
dc.subject.keywordPlus | BIOSIMILARS | - |
dc.subject.keywordAuthor | mAb | - |
dc.subject.keywordAuthor | Monosaccharide composition assay | - |
dc.subject.keywordAuthor | HPLC | - |
dc.subject.keywordAuthor | Validation | - |
dc.subject.keywordAuthor | ICH guideline | - |
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.
(02841) 서울특별시 성북구 안암로 14502-3290-1114
COPYRIGHT © 2021 Korea University. All Rights Reserved.
Certain data included herein are derived from the © Web of Science of Clarivate Analytics. All rights reserved.
You may not copy or re-distribute this material in whole or in part without the prior written consent of Clarivate Analytics.