Verification of the Final Anion Exchange Chromatography in the r-hGH Manufacturing Process
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 | Lee, Seung Heon | - |
dc.contributor.author | Park, Chulhwan | - |
dc.contributor.author | Kim, Seung Wook | - |
dc.contributor.author | Kim, Chan-Wha | - |
dc.date.accessioned | 2021-09-08T03:20:11Z | - |
dc.date.available | 2021-09-08T03:20:11Z | - |
dc.date.created | 2021-06-11 | - |
dc.date.issued | 2010-05 | - |
dc.identifier.issn | 1226-8372 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/116481 | - |
dc.description.abstract | In this study, final anion exchange chromatography in the recombinant human growth hormone (r-hGH) manufacturing process was validated using a validation protocol that was consistent with both policy and standard operation procedure (SOP). Two buffer solutions used in chromatography were first validated and were found to satisfy pre-established acceptance criteria as follows: pH: 8.2, endotoxin: <0.6 EU/mL, bioburden test: negative. Final anion exchange chromatography was conducted using a DEAE Sepharose FF Resin and eluted with a linear gradient of 30 to 110 mM NaCl in 50 mM Tris-HCl buffer at a flow rate of 15 L/h. Three consecutive batches of hGH solutions were generated via anion exchange chromatography, which was performed within pre-established operating parameters determined through in-process control. When all three batches were assessed by the pre-established sampling plan and tested for quality control, this purification process was shown to satisfy pre-established acceptance criteria; endotoxin: <= 0.5 EU/mg, ECP: <= 1.4 ppm, IEF: same removal distance, hGH content by Native-PAGE: 100%, purity by HPLC: >= 99%, yield by UV scanning: 87 to 89%, hGH monomer protein content by HPLC: 99%. Therefore, the final anion chromatography process was successfully validated in this study, and this method consistently yielded hGH solutions that satisfied pre-established criteria for subsequent processing. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | KOREAN SOC BIOTECHNOLOGY & BIOENGINEERING | - |
dc.subject | HUMAN GROWTH-HORMONE | - |
dc.subject | ESCHERICHIA-COLI | - |
dc.subject | EXPRESSION | - |
dc.subject | GENE | - |
dc.title | Verification of the Final Anion Exchange Chromatography in the r-hGH Manufacturing Process | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, Seung Wook | - |
dc.contributor.affiliatedAuthor | Kim, Chan-Wha | - |
dc.identifier.doi | 10.1007/s12257-009-3053-9 | - |
dc.identifier.scopusid | 2-s2.0-77956220276 | - |
dc.identifier.wosid | 000279632300018 | - |
dc.identifier.bibliographicCitation | BIOTECHNOLOGY AND BIOPROCESS ENGINEERING, v.15, no.3, pp.488 - 496 | - |
dc.relation.isPartOf | BIOTECHNOLOGY AND BIOPROCESS ENGINEERING | - |
dc.citation.title | BIOTECHNOLOGY AND BIOPROCESS ENGINEERING | - |
dc.citation.volume | 15 | - |
dc.citation.number | 3 | - |
dc.citation.startPage | 488 | - |
dc.citation.endPage | 496 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.identifier.kciid | ART001454508 | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.description.journalRegisteredClass | kci | - |
dc.relation.journalResearchArea | Biotechnology & Applied Microbiology | - |
dc.relation.journalWebOfScienceCategory | Biotechnology & Applied Microbiology | - |
dc.subject.keywordPlus | HUMAN GROWTH-HORMONE | - |
dc.subject.keywordPlus | ESCHERICHIA-COLI | - |
dc.subject.keywordPlus | EXPRESSION | - |
dc.subject.keywordPlus | GENE | - |
dc.subject.keywordAuthor | validation | - |
dc.subject.keywordAuthor | recombinant human growth hormone (r-hGH) | - |
dc.subject.keywordAuthor | acceptance criteria | - |
dc.subject.keywordAuthor | anion exchange chromatography | - |
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.