Validation for capture anion exchange chromatography process in r-hGH manufacturing
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Min, Byeong Jo | - |
dc.contributor.author | Kang, Seong Woo | - |
dc.contributor.author | Song, Yoon Seok | - |
dc.contributor.author | Lee, Jong Ho | - |
dc.contributor.author | Kim, Seung Wook | - |
dc.contributor.author | Park, Chulhwan | - |
dc.contributor.author | Kim, Chan Wha | - |
dc.date.accessioned | 2021-09-09T05:40:17Z | - |
dc.date.available | 2021-09-09T05:40:17Z | - |
dc.date.created | 2021-06-10 | - |
dc.date.issued | 2008-08 | - |
dc.identifier.issn | 1359-5113 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/122947 | - |
dc.description.abstract | The first anion exchange chromatography in the four chromatography steps of the r-hGH manufacturing process was validated in this study, using a validation protocol consistent with both policy and standard operation procedure (SOP). The first anion exchange chromatography was conducted with a DEAE Sepharose Fast Flow Resin equilibrated with 50 mM Tris-HCl buffer (pH 8.2). The activated r-hGH solution obtained from the inclusion body was loaded onto a column and eluted with a linear gradient of 80-300 mM Tris-HCl buffer (pH 8.2) at a flow rate of 25 L/h. Several buffer solutions used in the first anion exchange chromatography were first validated and satisfied the acceptance criteria preestablished as follows; pH: 8.2, endotoxin: <0.8 EU/mL, bioburden test: negative. Three consecutive lots of crude r-hGH solutions were generated via anion exchange chromatography, which was operated within the operating parameters pre-established via in-process control. When the intermediate products (crude Met-hGH solutions) of all three lots were assessed in accordance with the pre-established sampling plan and quality control tests, all three tested lots satisfied the acceptance criteria preestablished for the following purification process as fallows: endotoxin: <= 350 EU/mg, ECP: <= 42 ppm, IEF: same removal distance, r-hGH content in Native-PAGE: >73%, purity by HPLC: >= 86%, purification yield by UV scanning: 32-36%. Therefore, the first anion chromatography process was well validated in this study, and consistently yields crude r-hGH solutions that fulfill the pre-established criteria for the next purification process. (C) 2008 Elsevier Ltd. All rights reserved. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER SCI LTD | - |
dc.subject | HUMAN GROWTH-HORMONE | - |
dc.subject | ESCHERICHIA-COLI | - |
dc.subject | EXPRESSION | - |
dc.subject | OPTIMIZATION | - |
dc.subject | GENE | - |
dc.title | Validation for capture anion exchange chromatography process in r-hGH manufacturing | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, Seung Wook | - |
dc.contributor.affiliatedAuthor | Kim, Chan Wha | - |
dc.identifier.doi | 10.1016/j.procbio.2008.03.011 | - |
dc.identifier.scopusid | 2-s2.0-46849091762 | - |
dc.identifier.wosid | 000258396700003 | - |
dc.identifier.bibliographicCitation | PROCESS BIOCHEMISTRY, v.43, no.8, pp.808 - 815 | - |
dc.relation.isPartOf | PROCESS BIOCHEMISTRY | - |
dc.citation.title | PROCESS BIOCHEMISTRY | - |
dc.citation.volume | 43 | - |
dc.citation.number | 8 | - |
dc.citation.startPage | 808 | - |
dc.citation.endPage | 815 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Biochemistry & Molecular Biology | - |
dc.relation.journalResearchArea | Biotechnology & Applied Microbiology | - |
dc.relation.journalResearchArea | Engineering | - |
dc.relation.journalWebOfScienceCategory | Biochemistry & Molecular Biology | - |
dc.relation.journalWebOfScienceCategory | Biotechnology & Applied Microbiology | - |
dc.relation.journalWebOfScienceCategory | Engineering, Chemical | - |
dc.subject.keywordPlus | HUMAN GROWTH-HORMONE | - |
dc.subject.keywordPlus | ESCHERICHIA-COLI | - |
dc.subject.keywordPlus | EXPRESSION | - |
dc.subject.keywordPlus | OPTIMIZATION | - |
dc.subject.keywordPlus | GENE | - |
dc.subject.keywordAuthor | process validation | - |
dc.subject.keywordAuthor | human growth hormone (hGH) | - |
dc.subject.keywordAuthor | acceptance criteria | - |
dc.subject.keywordAuthor | anion exchange chromatography | - |
dc.subject.keywordAuthor | Escherichia coli | - |
dc.subject.keywordAuthor | purification | - |
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.
145 Anam-ro, Seongbuk-gu, Seoul, 02841, Korea+82-2-3290-2963
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.