利用质量设计优化重组人生长激素纯化工艺

Carolina Ortiz-Enriquez, A. J. Romero-Díaz, A. V. Hernández-Moreno, H. F. Cueto-Rojas, M. Miranda-Hernández, C. López-Morales, N. O. Pérez, Rodolfo Salazar-Ceballos, Norberto Cruz-García, L. F. Flores-Ortiz, E. Medina-Rivero
{"title":"利用质量设计优化重组人生长激素纯化工艺","authors":"Carolina Ortiz-Enriquez, A. J. Romero-Díaz, A. V. Hernández-Moreno, H. F. Cueto-Rojas, M. Miranda-Hernández, C. López-Morales, N. O. Pérez, Rodolfo Salazar-Ceballos, Norberto Cruz-García, L. F. Flores-Ortiz, E. Medina-Rivero","doi":"10.1080/10826068.2015.1135467","DOIUrl":null,"url":null,"abstract":"ABSTRACT This work describes a strategy to optimize a downstream processing of a recombinant human growth hormone (rhGH) by incorporating a quality by design approach toward meeting higher quality specifications. The optimized process minimized the presence of impurities and degradation by-products during manufacturing by the establishment of in-process controls. Capillary zone electrophoresis, reverse phase, and size-exclusion chromatographies were used as analytical techniques to establish new critical process parameters for the solubilization, capture, and intermediate purification steps aiming to maintain rhGH quality by complying with pharmacopeial specifications. The results indicated that the implemented improvements in the process allowed the optimization of the specific recovery and purification of rhGH without compromising its quality. In addition, this optimization facilitated the stringent removal of the remaining impurities in further polishing stages, as demonstrated by the analysis of the obtained active pharmaceutical ingredient.","PeriodicalId":20393,"journal":{"name":"Preparative Biochemistry and Biotechnology","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2016-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"3","resultStr":"{\"title\":\"Optimization of a recombinant human growth hormone purification process using quality by design\",\"authors\":\"Carolina Ortiz-Enriquez, A. J. Romero-Díaz, A. V. Hernández-Moreno, H. F. Cueto-Rojas, M. Miranda-Hernández, C. López-Morales, N. O. Pérez, Rodolfo Salazar-Ceballos, Norberto Cruz-García, L. F. Flores-Ortiz, E. Medina-Rivero\",\"doi\":\"10.1080/10826068.2015.1135467\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"ABSTRACT This work describes a strategy to optimize a downstream processing of a recombinant human growth hormone (rhGH) by incorporating a quality by design approach toward meeting higher quality specifications. The optimized process minimized the presence of impurities and degradation by-products during manufacturing by the establishment of in-process controls. Capillary zone electrophoresis, reverse phase, and size-exclusion chromatographies were used as analytical techniques to establish new critical process parameters for the solubilization, capture, and intermediate purification steps aiming to maintain rhGH quality by complying with pharmacopeial specifications. The results indicated that the implemented improvements in the process allowed the optimization of the specific recovery and purification of rhGH without compromising its quality. In addition, this optimization facilitated the stringent removal of the remaining impurities in further polishing stages, as demonstrated by the analysis of the obtained active pharmaceutical ingredient.\",\"PeriodicalId\":20393,\"journal\":{\"name\":\"Preparative Biochemistry and Biotechnology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2016-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"3\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Preparative Biochemistry and Biotechnology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1080/10826068.2015.1135467\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Preparative Biochemistry and Biotechnology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1080/10826068.2015.1135467","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 3

摘要

摘要:本研究描述了一种优化重组人生长激素(rhGH)下游加工的策略,通过结合质量设计方法来满足更高的质量规范。优化后的工艺通过建立过程控制,最大限度地减少了制造过程中杂质和降解副产物的存在。采用毛细管区带电泳、反相色谱和粒径隔离色谱作为分析技术,建立了新的关键工艺参数,用于增溶、捕获和中间纯化步骤,旨在通过符合药典规范来保持rhGH的质量。结果表明,在不影响rhGH质量的前提下,该工艺的改进优化了rhGH的回收率和纯化率。此外,这种优化有助于在进一步抛光阶段严格去除残留的杂质,正如所获得的活性药物成分的分析所证明的那样。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Optimization of a recombinant human growth hormone purification process using quality by design
ABSTRACT This work describes a strategy to optimize a downstream processing of a recombinant human growth hormone (rhGH) by incorporating a quality by design approach toward meeting higher quality specifications. The optimized process minimized the presence of impurities and degradation by-products during manufacturing by the establishment of in-process controls. Capillary zone electrophoresis, reverse phase, and size-exclusion chromatographies were used as analytical techniques to establish new critical process parameters for the solubilization, capture, and intermediate purification steps aiming to maintain rhGH quality by complying with pharmacopeial specifications. The results indicated that the implemented improvements in the process allowed the optimization of the specific recovery and purification of rhGH without compromising its quality. In addition, this optimization facilitated the stringent removal of the remaining impurities in further polishing stages, as demonstrated by the analysis of the obtained active pharmaceutical ingredient.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信