Application of the Quality-by-Design (QbD) Approach for Erythropoietin Alpha Purification
DC Field | Value | Language |
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dc.contributor.author | Kim, Tae Kyu | - |
dc.contributor.author | Seo, Kwang-Seok | - |
dc.contributor.author | Kwon, Sang-Oh | - |
dc.contributor.author | Little, Thomas A. | - |
dc.contributor.author | Kim, Mijung | - |
dc.contributor.author | Kim, Chan-Wha | - |
dc.date.accessioned | 2021-09-01T13:23:58Z | - |
dc.date.available | 2021-09-01T13:23:58Z | - |
dc.date.created | 2021-06-19 | - |
dc.date.issued | 2019-07 | - |
dc.identifier.issn | 0253-2964 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/64609 | - |
dc.description.abstract | This study was aimed at process characterization and improving quality of purification of erythropoietin alpha, a biopharmaceutical agent. In biopharmaceutical manufacturing, quality should always be targeted to ensure safety and efficacy. Design-of-experiments-based approaches have been explored to rapidly and efficiently achieve an optimized yield and an increased understanding of a product and process variables affecting the product's critical quality attributes in the biopharmaceutical industry; this system is known as the quality-by-design approach. Changes in three critical process parameters-buffer pH, flow rate, and loading amount-were evaluated. Process characterization was conducted on a scaled-down model previously validated by comparison with data from a large-scale production facility. Seven critical quality attributes-relative aggregate content, host cell protein, host cell deoxynucleotides, endotoxin, Z-value (N-glycan score), relative content of charge isomers, and step yield-were analyzed. Multivariate regression analysis was performed to establish statistical prediction models for performance indicators and quality attributes; accordingly, we constructed contour plots and conducted a Monte Carlo simulation to clarify the design space. As a result of the optimization analysis of the purification process, it was confirmed that proven acceptance ranges were optimized as follows: loading amount (mg/mL) 0.4-4.0, buffer pH 7.0-8.0, and flow rate (mL/min) 0.5-1.6. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | WILEY-V C H VERLAG GMBH | - |
dc.subject | NUMBER | - |
dc.title | Application of the Quality-by-Design (QbD) Approach for Erythropoietin Alpha Purification | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, Chan-Wha | - |
dc.identifier.doi | 10.1002/bkcs.11737 | - |
dc.identifier.scopusid | 2-s2.0-85066075458 | - |
dc.identifier.wosid | 000475685200003 | - |
dc.identifier.bibliographicCitation | BULLETIN OF THE KOREAN CHEMICAL SOCIETY, v.40, no.7, pp.623 - 633 | - |
dc.relation.isPartOf | BULLETIN OF THE KOREAN CHEMICAL SOCIETY | - |
dc.citation.title | BULLETIN OF THE KOREAN CHEMICAL SOCIETY | - |
dc.citation.volume | 40 | - |
dc.citation.number | 7 | - |
dc.citation.startPage | 623 | - |
dc.citation.endPage | 633 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.identifier.kciid | ART002487659 | - |
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 | NUMBER | - |
dc.subject.keywordAuthor | Erythropoietin alpha purification | - |
dc.subject.keywordAuthor | Design space | - |
dc.subject.keywordAuthor | Quality by design | - |
dc.subject.keywordAuthor | Critical quality attributes | - |
dc.subject.keywordAuthor | Critical process parameter | - |
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