M. Hoehse, José Alves-Rausch, A. Prediger, P. Roch, C. Grimm
The quality of upstream processes and their products strongly depends on the control of all influencing parameters. However, several relevant parameters are not measured in standard bioreactor systems. Near-infrared spectroscopy (NIRS) is one promising technology capable of becoming the missing link in sensor technology. This review gives an overview of the technological principles and the technological progress. A broad range of possible applications is presented, forming in its entirety a valuable toolbox for process risk mitigation. Recent applications of NIRS in upstream bioprocesses are discussed. Moreover, the review includes regulatory aspects in implementation, calibration and validation of NIRS instrumentation and models.
{"title":"Near-infrared spectroscopy in upstream bioprocesses","authors":"M. Hoehse, José Alves-Rausch, A. Prediger, P. Roch, C. Grimm","doi":"10.4155/PBP.15.1","DOIUrl":"https://doi.org/10.4155/PBP.15.1","url":null,"abstract":"The quality of upstream processes and their products strongly depends on the control of all influencing parameters. However, several relevant parameters are not measured in standard bioreactor systems. Near-infrared spectroscopy (NIRS) is one promising technology capable of becoming the missing link in sensor technology. This review gives an overview of the technological principles and the technological progress. A broad range of possible applications is presented, forming in its entirety a valuable toolbox for process risk mitigation. Recent applications of NIRS in upstream bioprocesses are discussed. Moreover, the review includes regulatory aspects in implementation, calibration and validation of NIRS instrumentation and models.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"3 1","pages":"153-172"},"PeriodicalIF":0.0,"publicationDate":"2015-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.15.1","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70350323","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}
G. E. Khoury, B. Khogeer, Chen Chen, Kheng T Ng, Shaleem I Jacob, C. Lowe
This article provides an overview of the current challenges and trends in bioprocessing, with a focus on recent advances in the affinity purification of the principal classes of biotherapeutics, including monoclonal antibodies, glycoproteins, vaccines and erythropoietin. Affinity chromatography is usually applied during large-scale protein purification; it involves affinity ligands of biological or synthetic origin. The high productivity that is currently achieved during upstream processing is placing an increasing burden on the downstream production phase which suffers from limited capacities. Consequently, while genetic engineering is helping to increase the stability and capacity of natural ligands, in silico approaches combined with combinatorial chemistry may be used to implement economical purification strategies based on synthetic ligands for the improvement of downstream processing and biomanufacturing.
{"title":"Bespoke affinity ligands for the purification of therapeutic proteins","authors":"G. E. Khoury, B. Khogeer, Chen Chen, Kheng T Ng, Shaleem I Jacob, C. Lowe","doi":"10.4155/PBP.14.60","DOIUrl":"https://doi.org/10.4155/PBP.14.60","url":null,"abstract":"This article provides an overview of the current challenges and trends in bioprocessing, with a focus on recent advances in the affinity purification of the principal classes of biotherapeutics, including monoclonal antibodies, glycoproteins, vaccines and erythropoietin. Affinity chromatography is usually applied during large-scale protein purification; it involves affinity ligands of biological or synthetic origin. The high productivity that is currently achieved during upstream processing is placing an increasing burden on the downstream production phase which suffers from limited capacities. Consequently, while genetic engineering is helping to increase the stability and capacity of natural ligands, in silico approaches combined with combinatorial chemistry may be used to implement economical purification strategies based on synthetic ligands for the improvement of downstream processing and biomanufacturing.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"3 1","pages":"139-152"},"PeriodicalIF":0.0,"publicationDate":"2015-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.14.60","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70348975","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}
Fabian Stiefel, Simon Fischer, M. Hackl, R. Handrick, F. Hesse, N. Borth, K. Otte, J. Grillari
Chinese hamster ovary cells are among the biotechnologically most relevant production systems for biopharmaceuticals. With the availability of the genomic sequences of Chinese hamster, rational systems biotechnology-driven approaches to optimize this cell factory have become available. Here, we review the current status of noncoding RNAs as members of the post-transcriptional operon concept in the context of Chinese hamster ovary cell line engineering and bioprocessing. In addition, we suggest that they already now keep their promises as tools for increasing specific productivity and thus time space yield of biopharmaceutical production, a feature that will allow for more cost efficient production processes in the future.
{"title":"Noncoding RNAs, post-transcriptional RNA operons and Chinese hamster ovary cells","authors":"Fabian Stiefel, Simon Fischer, M. Hackl, R. Handrick, F. Hesse, N. Borth, K. Otte, J. Grillari","doi":"10.4155/PBP.14.65","DOIUrl":"https://doi.org/10.4155/PBP.14.65","url":null,"abstract":"Chinese hamster ovary cells are among the biotechnologically most relevant production systems for biopharmaceuticals. With the availability of the genomic sequences of Chinese hamster, rational systems biotechnology-driven approaches to optimize this cell factory have become available. Here, we review the current status of noncoding RNAs as members of the post-transcriptional operon concept in the context of Chinese hamster ovary cell line engineering and bioprocessing. In addition, we suggest that they already now keep their promises as tools for increasing specific productivity and thus time space yield of biopharmaceutical production, a feature that will allow for more cost efficient production processes in the future.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"3 1","pages":"227-247"},"PeriodicalIF":0.0,"publicationDate":"2015-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.14.65","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70349740","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}
R. Bareither, M. Goldfeld, C. Kistler, A. Tait, Neil Bargh, R. Oakeshott, Kristin M. O’Neill, Linda Hoshan, D. Pollard
Aim: A disposable reactor system (250 ml scale) has now been developed into a fully automated 24 reactor array which includes process parameter monitoring and control, advanced feed strategies, automated event triggering, robotic arm liquid handling and sample storage. Results: Process and analytical comparability was shown for a range of Pichia, Escherichia coli and CHO cell-culture bioprocesses up to pilot and commercial scale. This established the system as a scale-down model for process development and characterization of large-scale industrial processes. Conclusion: This work demonstrated the ability of the automated system to accelerate process development by executing a single statistical design of experiments, with a wider range of parameters, up to 3–5-times faster than conventional approaches.
{"title":"Automated disposable small-scale bioreactor for high-throughput process development: implementation of the 24 bioreactor array","authors":"R. Bareither, M. Goldfeld, C. Kistler, A. Tait, Neil Bargh, R. Oakeshott, Kristin M. O’Neill, Linda Hoshan, D. Pollard","doi":"10.4155/PBP.14.64","DOIUrl":"https://doi.org/10.4155/PBP.14.64","url":null,"abstract":"Aim: A disposable reactor system (250 ml scale) has now been developed into a fully automated 24 reactor array which includes process parameter monitoring and control, advanced feed strategies, automated event triggering, robotic arm liquid handling and sample storage. Results: Process and analytical comparability was shown for a range of Pichia, Escherichia coli and CHO cell-culture bioprocesses up to pilot and commercial scale. This established the system as a scale-down model for process development and characterization of large-scale industrial processes. Conclusion: This work demonstrated the ability of the automated system to accelerate process development by executing a single statistical design of experiments, with a wider range of parameters, up to 3–5-times faster than conventional approaches.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"3 1","pages":"185-197"},"PeriodicalIF":0.0,"publicationDate":"2015-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.14.64","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70349576","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}
{"title":"Pushing the limits of high-throughput chromatography process development: current state and future directions","authors":"J. Welsh","doi":"10.4155/PBP.14.40","DOIUrl":"https://doi.org/10.4155/PBP.14.40","url":null,"abstract":"","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"3 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2015-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.14.40","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70348068","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}
The field of biomanufacturing employs many single-use (SU) systems for features such as lower initial investment and reduced time-to-market. Continuous manufacturing methods can provide increased product quality and process control, and reduced operating costs. Continuous biomanufacturing (CB) additionally promises reduced classified area extent, personnel requirements and operating steps. The benefits of SU CB include heightened processing parameter consistency and increased process flexibility. Perfusion culture (PC) is supported by many specialized SU and hybrid bioreactors. These and many accessory perfusion-enabling technologies are the main way of implementing upstream CB. Valuable features provided by PC include reduced product reactor-residency and increased reactor-volumetric productivity. SU PC supports the dream of enterprise managed, modular, end-to-end integrated and closed CB providing higher environmental sustainability.
{"title":"Single-use perfusion bioreactors support continuous biomanufacturing","authors":"W. Whitford","doi":"10.4155/PBP.14.58","DOIUrl":"https://doi.org/10.4155/PBP.14.58","url":null,"abstract":"The field of biomanufacturing employs many single-use (SU) systems for features such as lower initial investment and reduced time-to-market. Continuous manufacturing methods can provide increased product quality and process control, and reduced operating costs. Continuous biomanufacturing (CB) additionally promises reduced classified area extent, personnel requirements and operating steps. The benefits of SU CB include heightened processing parameter consistency and increased process flexibility. Perfusion culture (PC) is supported by many specialized SU and hybrid bioreactors. These and many accessory perfusion-enabling technologies are the main way of implementing upstream CB. Valuable features provided by PC include reduced product reactor-residency and increased reactor-volumetric productivity. SU PC supports the dream of enterprise managed, modular, end-to-end integrated and closed CB providing higher environmental sustainability.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"3 1","pages":"75-93"},"PeriodicalIF":0.0,"publicationDate":"2015-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.14.58","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70348910","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}
While sophisticated analytical tools and models for operations and supply chain management are increasingly used in many industries, the biopharmaceutical industry lags many others in terms of applying these approaches. We survey the (relatively small number of) papers that explore the use of analytical models to address various strategic, tactical and operational issues in biopharmaceutical operations and supply chain management, discuss gaps in current knowledge, and identify opportunities to further extend the state-of-the art in this area.
{"title":"Analytical models for biopharmaceutical operations and supply chain management: a survey of research literature","authors":"Philip M. Kaminsky, Yang Wang","doi":"10.4155/PBP.14.57","DOIUrl":"https://doi.org/10.4155/PBP.14.57","url":null,"abstract":"While sophisticated analytical tools and models for operations and supply chain management are increasingly used in many industries, the biopharmaceutical industry lags many others in terms of applying these approaches. We survey the (relatively small number of) papers that explore the use of analytical models to address various strategic, tactical and operational issues in biopharmaceutical operations and supply chain management, discuss gaps in current knowledge, and identify opportunities to further extend the state-of-the art in this area.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"3 1","pages":"61-73"},"PeriodicalIF":0.0,"publicationDate":"2015-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.14.57","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70348848","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}
Vaccination has been the most effective and economical way of combating the spread of infectious disease. Virus-like particles (VLPs) against human and animal diseases caused by picornaviruses are actively being researched and developed as potential vaccines. Promising immunogenicity and protective efficacy data has been reported for VLPs produced using various expression systems. The translation of these VLPs into vaccine products requires further bioprocess development, underpinned by advanced analytical VLP characterization techniques. We overview approaches taken to effectively produce and purify these multiprotein VLPs to achieve the desired immune responses. The opportunities for developing VLP bioprocessing technologies for cost-effective and efficient vaccine manufacturing are highlighted.
{"title":"Development of picornavirus-like particle vaccines","authors":"Balaji Somasundaram, L. Lua","doi":"10.4155/PBP.14.39","DOIUrl":"https://doi.org/10.4155/PBP.14.39","url":null,"abstract":"Vaccination has been the most effective and economical way of combating the spread of infectious disease. Virus-like particles (VLPs) against human and animal diseases caused by picornaviruses are actively being researched and developed as potential vaccines. Promising immunogenicity and protective efficacy data has been reported for VLPs produced using various expression systems. The translation of these VLPs into vaccine products requires further bioprocess development, underpinned by advanced analytical VLP characterization techniques. We overview approaches taken to effectively produce and purify these multiprotein VLPs to achieve the desired immune responses. The opportunities for developing VLP bioprocessing technologies for cost-effective and efficient vaccine manufacturing are highlighted.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"3 1","pages":"45-59"},"PeriodicalIF":0.0,"publicationDate":"2015-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.14.39","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70347542","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}
Mammalian cells are routinely used in the biopharmaceutical industry for production of recombinant therapeutic proteins. Cell banking to ensure preservation of these cells at low temperatures for an extended period of time is at the core of establishing a manufacturing process utilizing these cells and various strategies have evolved over time to ensure recovery of viable ‘and’ functional cells. This paper provides an overview of cryopreservation practices and highlights recent approaches that have been adopted to improve cryopreservation outcomes for these industrially relevant production cell lines.
{"title":"Recent advances in optimal cell banking of mammalian cells for biopharmaceutical production","authors":"Gargi Seth","doi":"10.4155/PBP.14.46","DOIUrl":"https://doi.org/10.4155/PBP.14.46","url":null,"abstract":"Mammalian cells are routinely used in the biopharmaceutical industry for production of recombinant therapeutic proteins. Cell banking to ensure preservation of these cells at low temperatures for an extended period of time is at the core of establishing a manufacturing process utilizing these cells and various strategies have evolved over time to ensure recovery of viable ‘and’ functional cells. This paper provides an overview of cryopreservation practices and highlights recent approaches that have been adopted to improve cryopreservation outcomes for these industrially relevant production cell lines.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"3 1","pages":"35-43"},"PeriodicalIF":0.0,"publicationDate":"2015-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4155/PBP.14.46","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70348200","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}
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