发布求助
文献互助 智能选刊 最新文献

Pharmaceutical bioprocessing最新文献

筛选
英文 中文
The application of systems biology to biomanufacturing 系统生物学在生物制造中的应用
Pharmaceutical bioprocessing Pub Date : 2015-06-25 DOI: 10.4155/PBP.15.12
Larissa M Benavente, Adam S. Goldberg, H. Myburg, Joseph M. Chiera, Michael Zapata, L. V. Zyl
{"title":"The application of systems biology to biomanufacturing","authors":"Larissa M Benavente, Adam S. Goldberg, H. Myburg, Joseph M. Chiera, Michael Zapata, L. V. Zyl","doi":"10.4155/PBP.15.12","DOIUrl":"https://doi.org/10.4155/PBP.15.12","url":null,"abstract":"‘omics and systems biology have led to paradigm shifts in biology and medicine. This success has drawn the attention of the bioprocessing industry where their application is increasingly more prevalent. systems biology uses system-level high dimensional data generated via ‘omics technologies to provide a holistic view of the production cell lines. We discuss how systems biology drives rational process improvement and cell engineering strategies, highlighting seminal studies in prokaryotes and mammalian cell lines that combined multi-‘omics and modeling to provide insights into the behavior of production cell lines. Despite its recognized potential, there are challenges and limitations to overcome to fully implement and realize benefits heralded by systems biology for biomanufacturing: increasing titer, yield, quality, process efficiency and stability.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"3 1","pages":"341-355"},"PeriodicalIF":0.0,"publicationDate":"2015-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.15.12","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70352088","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Toward a two-tier process-development paradigm: prototype versus commercial biomanufacturing 走向两层工艺开发范式:原型与商业生物制造
Pharmaceutical bioprocessing Pub Date : 2015-06-18 DOI: 10.4155/PBP.15.5
J. Zurdo
{"title":"Toward a two-tier process-development paradigm: prototype versus commercial biomanufacturing","authors":"J. Zurdo","doi":"10.4155/PBP.15.5","DOIUrl":"https://doi.org/10.4155/PBP.15.5","url":null,"abstract":"Speed is often positioned as a key element in the development of any novel therapeutic. After all, reducing development timelines can have a beneficial impact in managing investment cycles (crucial for small biotech), facilitate the introduction of translational medicine (bench to bedside and back to bench) and extend market exclusivity awarded by intellectual property rights. Yet speed is precisely a largely absent attribute in the development of virtually any new drug, and we could argue that biopharmaceuticals, because of the intrinsic complexities associated with their production, are perhaps the worst positioned amongst most drug classes. As an optimistic estimate, the road for a lead biopharmaceutical candidate to reach first-in-human clinical trials could take between 1.5 and 2 years of, sometimes perilous, travel involving a considerable out-ofpocket investment at a very high risk. High risk because an immense majority of products in development will fail (sometimes catastrophically) at some point during their development. Below I discuss how past development and manufacturing challenges during the onset of biopharmaceuticals have conditioned the evolution of manufacturing praxis and the perception of risk in the industry. I would also like to discuss how a two-tier manufacturing paradigm, addressing separately early prototype versus commercial requirements, could change dramatically how biopharmaceutical development is approached today, perhaps opening the door to new treatments for medical conditions that today are still largely out-of-reach for protein-based therapeutics, such as infectious diseases.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"3 1","pages":"179-183"},"PeriodicalIF":0.0,"publicationDate":"2015-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.15.5","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70352841","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Development of protein-free medium for therapeutic protein production in mammalian cells: recent advances and perspectives 用于哺乳动物细胞治疗性蛋白生产的无蛋白培养基的开发:最新进展和前景
Pharmaceutical bioprocessing Pub Date : 2015-06-18 DOI: 10.4155/PBP.15.8
W. L. Ling
{"title":"Development of protein-free medium for therapeutic protein production in mammalian cells: recent advances and perspectives","authors":"W. L. Ling","doi":"10.4155/PBP.15.8","DOIUrl":"https://doi.org/10.4155/PBP.15.8","url":null,"abstract":"Mammalian cell culture media used for the manufacture of therapeutic protein have advanced systematically from serum-containing into animal-free, protein-free and chemically defined formulations over the past decades. Initially driven by patient safety concerns associated with the use of animal-derived medium components, and later by inconsistent cell culture performance due to variability in plant-derived raw material lots, many biologics manufacturers redirect their focus on the development of proprietary media formulations and implementation of well-controlled chemically defined raw materials in all cell culture media and feeds for production processes. This article will provide an overview of current trends and objectives of industrial medium development efforts for therapeutic protein production.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"3 1","pages":"215-226"},"PeriodicalIF":0.0,"publicationDate":"2015-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.15.8","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70353051","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 16
Multimodal chromatography: debottlenecking the downstream processing of monoclonal antibodies 多模态色谱:消除单克隆抗体下游加工的瓶颈
Pharmaceutical bioprocessing Pub Date : 2015-06-18 DOI: 10.4155/PBP.15.7
I. Pinto, M. Aires-Barros, A. Azevedo
{"title":"Multimodal chromatography: debottlenecking the downstream processing of monoclonal antibodies","authors":"I. Pinto, M. Aires-Barros, A. Azevedo","doi":"10.4155/PBP.15.7","DOIUrl":"https://doi.org/10.4155/PBP.15.7","url":null,"abstract":"The commercial potential of monoclonal antibodies (mAbs) has been continuously increasing during the last years alongside with the number of approved mAb-based drugs and clinical trials. Despite their effectiveness and safety, the general access to this class of biopharmaceuticals is barred by high selling prices. Downstream processing is now considered the bottleneck in the manufacturing of mAbs. Therefore, the design of novel and economic operations and their implementation in the current technology platforms constitutes a pressing need. This review provides an insight into the current state-of-the-art in mAbs purification, focusing on multimodal chromatography as one of the viable options to upgrade the established purification train.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"220 1","pages":"263-279"},"PeriodicalIF":0.0,"publicationDate":"2015-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.15.7","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70352515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 38
Antibody immunogenicity: does bioprocessing hold all the answers? 抗体免疫原性:生物处理能解决所有问题吗?
Pharmaceutical bioprocessing Pub Date : 2015-06-18 DOI: 10.4155/PBP.15.4
H. Waldmann
{"title":"Antibody immunogenicity: does bioprocessing hold all the answers?","authors":"H. Waldmann","doi":"10.4155/PBP.15.4","DOIUrl":"https://doi.org/10.4155/PBP.15.4","url":null,"abstract":"","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"3 1","pages":"175-177"},"PeriodicalIF":0.0,"publicationDate":"2015-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.15.4","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70352772","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Glutamine substitution: the role it can play to enhance therapeutic protein production 谷氨酰胺替代:提高治疗性蛋白质生产的作用
Pharmaceutical bioprocessing Pub Date : 2015-06-18 DOI: 10.4155/PBP.15.6
T. Ha, G. Lee
{"title":"Glutamine substitution: the role it can play to enhance therapeutic protein production","authors":"T. Ha, G. Lee","doi":"10.4155/PBP.15.6","DOIUrl":"https://doi.org/10.4155/PBP.15.6","url":null,"abstract":"The biopharmaceutical market is driven by the steady increase in demand for therapeutic proteins produced in mammalian cells. Glutamine is a main nitrogen source and also a main energy source with glucose in mammalian cell cultures for therapeutic protein production. As a result of glutamine metabolism and the natural decomposition of glutamine, ammonia, which is known to negatively affect cell growth, protein production and sialylation of recombinant glycoprotein, is necessarily accumulated in a culture medium. This review highlights the current strategies and achievements in overcoming the negative effect of ammonia through the glutamine substitution by less ammoniagenic substrates, such as glutamate, pyruvate and α-ketoglutarate.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"3 1","pages":"249-261"},"PeriodicalIF":0.0,"publicationDate":"2015-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.15.6","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70352906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 8
Exploring standards for industrializing human induced pluripotent stem cells 探索人类诱导多能干细胞产业化标准
Pharmaceutical bioprocessing Pub Date : 2015-06-18 DOI: 10.4155/PBP.15.9
Hidemasa Kato, Keiko Hiraki-Kamon, M. Eitoku, H. Kiyosawa, C. Neeley, Y. Okazaki
{"title":"Exploring standards for industrializing human induced pluripotent stem cells","authors":"Hidemasa Kato, Keiko Hiraki-Kamon, M. Eitoku, H. Kiyosawa, C. Neeley, Y. Okazaki","doi":"10.4155/PBP.15.9","DOIUrl":"https://doi.org/10.4155/PBP.15.9","url":null,"abstract":"Popular belief assumes that human pluripotent cells can now be obtained in any lab or company by induced pluripotent stem (iPS) cell reprogramming. However, the difficulties in robustly producing human iPS-derived cells that are fit for drug discovery are becoming increasingly apparent. This is because we still have not come up with a strict definition of pluripotency. Our attempts at prospectively identifying differentiation-defective human iPS cells using teratoma assays or marker expression have clearly failed to date. Here, we will revisit how conventional pluripotency tests have failed in evaluating iPS cells adequately for drug discovery and emphasize two aspects of developmental transitions (what we call here a cell's chronological value and the segregation of factors as it differentiates) to elucidate inherent problems with our current understanding of human iPS cells. Finally, we challenge the field by presenting our perspective on distinguishing good human iPS cells from bad ones.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"3 1","pages":"199-213"},"PeriodicalIF":0.0,"publicationDate":"2015-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.15.9","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70353152","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Industrial application of impurity flocculation to streamline antibody purification processes 杂质絮凝在简化抗体纯化过程中的工业应用
Pharmaceutical bioprocessing Pub Date : 2015-04-30 DOI: 10.4155/PBP.15.2
Michael Felo, Y. Kang, James A. Hamzik, P. Balderes, D. Ludwig
{"title":"Industrial application of impurity flocculation to streamline antibody purification processes","authors":"Michael Felo, Y. Kang, James A. Hamzik, P. Balderes, D. Ludwig","doi":"10.4155/PBP.15.2","DOIUrl":"https://doi.org/10.4155/PBP.15.2","url":null,"abstract":"Flocculation technologies offer significant benefits to industrial mammalian cell culture processes, including increased clarification efficiency, impurity removal and process simplification. In this paper, the application and performance of flocculation technologies employed in the harvest process of monoclonal antibody Chinese hamster ovary cell culture are reviewed. Attention has been placed on technologies enhancing the removal of cells, cellular debris and reduction in impurities while maintaining the antibody in the product stream. Many flocculants are systematically evaluated with respect to their mechanism of action, impact on downstream processing and product quality, and potential disadvantages. Practical considerations and future directions for application of flocculation in antibody manufacturing are discussed.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"3 1","pages":"115-125"},"PeriodicalIF":0.0,"publicationDate":"2015-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.15.2","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70352411","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 9
Steady-state biofilm cultivation of Aspergillus niger D15 in a ceramic capillary membrane bioreactor 陶瓷毛细管膜生物反应器中黑曲霉D15的稳态生物膜培养
Pharmaceutical bioprocessing Pub Date : 2015-04-30 DOI: 10.4155/PBP.14.61
C. Endres, S. J. Fraser, W. Edwards, S. Beutel, T. Scheper
{"title":"Steady-state biofilm cultivation of Aspergillus niger D15 in a ceramic capillary membrane bioreactor","authors":"C. Endres, S. J. Fraser, W. Edwards, S. Beutel, T. Scheper","doi":"10.4155/PBP.14.61","DOIUrl":"https://doi.org/10.4155/PBP.14.61","url":null,"abstract":"Aim: Bioreactors are an essential component in every biotechnological process. Due to the multitude of different microbial and mammalian organisms used for production of complex products, novel concepts for customized cultivations are necessary. Results: A ceramic capillary-based bioreactor enabling a novel approach for steady-state biofilm cultivation is presented. A model for the determination of the efficiency of this system was developed by comparing its productivity to conventional stirred tank reactors using the production of recombinant xylanase by Aspergillus niger D15 (xyn2) as a model process. Conclusion: The presented bioreactor provides an ideal platform for the cultivation of shear-sensitive, filamentous growing microorganisms producing valuable secreted secondary metabolites or recombinant products.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"3 1","pages":"101-113"},"PeriodicalIF":0.0,"publicationDate":"2015-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.14.61","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70349052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Viral clearance for biopharmaceutical downstream processes 生物制药下游工艺的病毒清除
Pharmaceutical bioprocessing Pub Date : 2015-04-30 DOI: 10.4155/PBP.14.62
A. Shukla, H. Aranha
{"title":"Viral clearance for biopharmaceutical downstream processes","authors":"A. Shukla, H. Aranha","doi":"10.4155/PBP.14.62","DOIUrl":"https://doi.org/10.4155/PBP.14.62","url":null,"abstract":"Viral clearance studies are mandated prior to entering clinical trials and for commercial launch of biopharmaceuticals. These studies are a key component of risk mitigation to reduce the potential for iatrogenic transmission of pathogenic viruses. This paper reviews regulatory guidance and practical strategies for designing viral clearance studies. Essential elements of a developmental phase-appropriate viral clearance package are detailed. These include scale-down model qualification, virus spike experiments and validation (clearance evaluation) of manufacturing process steps. Heuristics and learnings from available data are shared. Developments in this area including generic validation strategies, multiviral spiking strategies and use of newer model viruses for nonconventional substrates are also described. This review provides a framework for a comprehensive viral validation package for regulatory submissions.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"3 1","pages":"127-138"},"PeriodicalIF":0.0,"publicationDate":"2015-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.14.62","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70349145","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 36
首页 上一页 下一页 尾页
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
现在去查看 取消
×
提示
确定
请完成安全验证×
相关产品
×
本文献相关产品
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：604180095
Book学术官方微信
小红书