Comparability studies of new 3rd generation recombinant human factor VIII GreenGene F after improvement of formulation and viral inactivation/removal process
DC Field | Value | Language |
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dc.contributor.author | Paik, Sang Hoon | - |
dc.contributor.author | Kim, Yong Jae | - |
dc.contributor.author | Han, Sang Kyul | - |
dc.contributor.author | Kim, Ji-youn | - |
dc.contributor.author | Park, Hanna | - |
dc.contributor.author | Park, Young In | - |
dc.date.accessioned | 2021-09-06T14:00:25Z | - |
dc.date.available | 2021-09-06T14:00:25Z | - |
dc.date.created | 2021-06-14 | - |
dc.date.issued | 2012-11 | - |
dc.identifier.issn | 1045-1056 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/107129 | - |
dc.description.abstract | A new 3rd generation recombinant factor VIII (rFVIII), GreenGene F (WHO INN: beroctocog alfa), which is a highly homogenous B-domain deleted FVIII protein comprising of two peptides as heavy chain (A1 and A2 domain) and light chain (A3, C1, and C2 domain) at 80 and 90 kDa, was developed from its predecessor product GreenGene (2nd generation product previously approved by Korea FDA after clinical studies in South Korea) by process improvements of i) addition of Solvent/Detergent treatment for virus inactivation, ii) nanofiltration (20 nm pore size) for viral removal and iii) alterations to an albumin-free formulation to minimize the risk of viral contamination. An assessment of comparability between the two products was made to see if process improvements for safer product manufacturing affected the rFVIII structural and functional characteristics. Physicochemical and physiological characteristics were observed, in vivo efficacy following a single intravenous administration to FVIII knock-out mice and toxicity by various GLP in vivo tests were evaluated. All results showed equivalence, proving that no changes in protein characteristics of rFVIII occurred from process changes in formulation, viral inactivation, and viral removal which minimize the risk of pathogen transmission to enhance safety. (C) 2012 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD | - |
dc.subject | PLASMA/ALBUMIN-FREE METHOD | - |
dc.subject | TREATED PLASMA | - |
dc.subject | SAFETY | - |
dc.subject | THERAPY | - |
dc.subject | ISSUES | - |
dc.title | Comparability studies of new 3rd generation recombinant human factor VIII GreenGene F after improvement of formulation and viral inactivation/removal process | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Park, Young In | - |
dc.identifier.doi | 10.1016/j.biologicals.2012.09.004 | - |
dc.identifier.scopusid | 2-s2.0-84868343352 | - |
dc.identifier.wosid | 000311596700002 | - |
dc.identifier.bibliographicCitation | BIOLOGICALS, v.40, no.6, pp.405 - 414 | - |
dc.relation.isPartOf | BIOLOGICALS | - |
dc.citation.title | BIOLOGICALS | - |
dc.citation.volume | 40 | - |
dc.citation.number | 6 | - |
dc.citation.startPage | 405 | - |
dc.citation.endPage | 414 | - |
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 | Pharmacology & Pharmacy | - |
dc.relation.journalWebOfScienceCategory | Biochemical Research Methods | - |
dc.relation.journalWebOfScienceCategory | Biotechnology & Applied Microbiology | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.subject.keywordPlus | PLASMA/ALBUMIN-FREE METHOD | - |
dc.subject.keywordPlus | TREATED PLASMA | - |
dc.subject.keywordPlus | SAFETY | - |
dc.subject.keywordPlus | THERAPY | - |
dc.subject.keywordPlus | ISSUES | - |
dc.subject.keywordAuthor | B-Domain deleted recombinant factor VIII | - |
dc.subject.keywordAuthor | GreenGene F | - |
dc.subject.keywordAuthor | Homogeneous FVIII | - |
dc.subject.keywordAuthor | Comparability | - |
dc.subject.keywordAuthor | Viral inactivation | - |
dc.subject.keywordAuthor | Protein characteristics | - |
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