Economic Analysis of Batch and Continuous Biopharmaceutical Antibody Production: a Review
暂无分享,去创建一个
[1] Kurt Brorson,et al. The Current Scientific and Regulatory Landscape in Advancing Integrated Continuous Biopharmaceutical Manufacturing. , 2019, Trends in biotechnology.
[2] José González-Valdez,et al. Novel Aspects and Future Trends in The Use of Aqueous Two-Phase System as a Bioengineering Tool , 2018 .
[3] Ana M Azevedo,et al. Chromatography-free recovery of biopharmaceuticals through aqueous two-phase processing. , 2009, Trends in biotechnology.
[4] Suzanne S. Farid,et al. Economic Drivers and Trade-Offs in Antibody Purification Processes : The future of therapeutic MAbs lies in the development of economically feasible downstream processes , 2008 .
[5] William G. Whitford,et al. Single‐Use Systems Support Continuous Bioprocessing by Perfusion Culture , 2014 .
[7] Hemanthram Varadaraju,et al. Process and economic evaluation for monoclonal antibody purification using a membrane‐only process , 2011, Biotechnology progress.
[8] Marco Rito-Palomares,et al. Continuous aqueous two-phase systems devices for the recovery of biological products , 2014 .
[9] Gavin Towler,et al. Chemical engineering design : principles, practice, and economics of plant and process design , 2008 .
[10] Rene Gantier,et al. A straightforward methodology for designing continuous monoclonal antibody capture multi-column chromatography processes. , 2015, Journal of chromatography. A.
[11] Jonathan P. Raftery,et al. Economic improvement of continuous pharmaceutical production via the optimal control of a multifeed bioreactor , 2017, Biotechnology progress.
[12] Suzanne S Farid,et al. Integrated continuous bioprocessing: Economic, operational, and environmental feasibility for clinical and commercial antibody manufacture , 2017, Biotechnology progress.
[13] B. Ogunnaike,et al. Controlling the Glycosylation Profile in mAbs Using Time-Dependent Media Supplementation , 2017, Antibodies.
[14] Suzanne S Farid,et al. Established bioprocesses for producing antibodies as a basis for future planning. , 2006, Advances in biochemical engineering/biotechnology.
[15] W. Shrank,et al. Pricing of monoclonal antibody therapies: higher if used for cancer? , 2018, The American journal of managed care.
[16] Paola Lettieri,et al. Life‐cycle and cost of goods assessment of fed‐batch and perfusion‐based manufacturing processes for mAbs , 2016, Biotechnology progress.
[17] Uwe Gottschalk,et al. Single-use disposable technologies for biopharmaceutical manufacturing. , 2013, Trends in biotechnology.
[18] Jochen Strube,et al. Trends in Upstream and Downstream Process Development for Antibody Manufacturing. , 2014, Bioengineering.
[19] Eva Sorensen,et al. Design of high productivity sequential multi-column chromatography for antibody capture , 2014 .
[20] Fernando L. Taracena. An Economic Analysis for Product and Process Design , 2006 .
[21] Rashmi Kshirsagar,et al. Concentrated fed-batch cell culture increases manufacturing capacity without additional volumetric capacity. , 2016, Journal of biotechnology.
[22] John Ahmet Erkoyuncu,et al. Discrete Event Simulation Modelling for Dynamic Decision Making in Biopharmaceutical Manufacturing , 2016 .
[23] James Hayes,et al. Identifying a robust design space for glycosylation during monoclonal antibody production , 2016, Biotechnology progress.
[25] Andrew D. Tustian,et al. Purification of monoclonal antibodies from clarified cell culture fluid using Protein A capture continuous countercurrent tangential chromatography. , 2015, Journal of biotechnology.
[26] Massimo Morbidelli,et al. Twin-column CaptureSMB: a novel cyclic process for protein A affinity chromatography. , 2015, Journal of chromatography. A.
[27] Michael C. Flickinger,et al. Upstream industrial biotechnology , 2013 .
[28] Adriana G. Lopes,et al. Single-use in the biopharmaceutical industry: A review of current technology impact, challenges and limitations , 2015 .
[29] G. Schembecker,et al. Continuous viral inactivation at low pH value in antibody manufacturing , 2016 .
[30] N J Titchener-Hooker,et al. Economic comparison between conventional and disposables-based technology for the production of biopharmaceuticals. , 2001, Biotechnology and bioengineering.
[31] P. Ashouri,et al. A dynamic simulation framework for biopharmaceutical capacity management , 2011 .
[32] Konstantin Konstantinov,et al. End-to-end integrated fully continuous production of recombinant monoclonal antibodies. , 2015, Journal of biotechnology.
[33] I. Apostol,et al. Monoclonal antibody disulfide reduction during manufacturing , 2013, mAbs.
[34] Andrew L. Zydney,et al. Continuous Countercurrent Tangential Chromatography for Monoclonal Antibody Purification , 2013 .
[35] Masahiko Hirao,et al. Erratum to: Decision-Support Method for the Choice Between Single-Use and Multi-Use Technologies in Sterile Drug Product Manufacturing , 2017, Journal of Pharmaceutical Innovation.
[36] Kristina Pleitt,et al. Progression of continuous downstream processing of monoclonal antibodies: Current trends and challenges , 2018, Biotechnology and bioengineering.
[37] Gerhard Schembecker,et al. Cost evaluation of antibody production processes in different operation modes , 2016 .
[38] Mario A Torres-Acosta,et al. Economic analysis of uricase production under uncertainty: Contrast of chromatographic purification and aqueous two‐phase extraction (with and without PEG recycle) , 2015, Biotechnology progress.
[39] Sen Xu,et al. Bioreactor productivity and media cost comparison for different intensified cell culture processes , 2017, Biotechnology progress.
[40] Lazaros G. Papageorgiou,et al. Integrated Optimization of Upstream and Downstream Processing in Biopharmaceutical Manufacturing under Uncertainty: A Chance Constrained Programming Approach , 2016 .
[41] José González-Valdez,et al. Aqueous Two‐Phase Systems at Large Scale: Challenges and Opportunities , 2018, Biotechnology journal.
[42] Massimo Morbidelli,et al. Continuous counter‐current chromatography for capture and polishing steps in biopharmaceutical production , 2016, Biotechnology journal.
[43] L. Castilho. Continuous Animal Cell Perfusion Processes: The First Step Toward Integrated Continuous Biomanufacturing , 2014 .
[44] Eric S. Langer,et al. Single‐use technologies in biopharmaceutical manufacturing: A 10‐year review of trends and the future , 2014 .
[45] Alois Jungbauer,et al. Economics of recombinant antibody production processes at various scales: Industry-standard compared to continuous precipitation. , 2014, Biotechnology journal.
[46] Anirudh M. K. Nambiar,et al. Countercurrent staged diafiltration for formulation of high value proteins , 2018, Biotechnology and bioengineering.
[47] P. Shamlou,et al. Design, construction, and optimization of a novel, modular, and scalable incubation chamber for continuous viral inactivation , 2017, Biotechnology progress.
[48] Mark Pagkaliwangan,et al. Modeling the Downstream Processing of Monoclonal Antibodies Reveals Cost Advantages for Continuous Methods for a Broad Range of Manufacturing Scales , 2019, Biotechnology journal.
[49] An integrated practical implementation of continuous aqueous two-phase systems for the recovery of human IgG: From the microdevice to a multistage bench-scale mixer-settler device. , 2016, Biotechnology journal.
[50] Zheng Jian Li,et al. Investigation of single-pass tangential flow filtration (SPTFF) as an inline concentration step for cell culture harvest , 2017 .
[51] A. Zydney,et al. Performance optimization of continuous countercurrent tangential chromatography for antibody capture , 2016, Biotechnology progress.
[52] Brian Kelley,et al. Industrialization of mAb production technology: The bioprocessing industry at a crossroads , 2009, mAbs.
[53] Anurag S Rathore,et al. Continuous Processing for Production of Biopharmaceuticals , 2015, Preparative biochemistry & biotechnology.
[54] Daniel G Bracewell,et al. Optimising the design and operation of semi-continuous affinity chromatography for clinical and commercial manufacture. , 2013, Journal of chromatography. A.
[55] Satoshi Ohtake,et al. Cell-Free Synthesis Meets Antibody Production: A Review , 2015 .
[56] Lindsay Arnold,et al. Implementation of Fully Integrated Continuous Antibody Processing: Effects on Productivity and COGm , 2019, Biotechnology journal.
[57] Mario A Torres-Acosta,et al. Economic evaluation of the primary recovery of tetracycline with traditional and novel aqueous two-phase systems , 2018, Separation and purification technology.
[58] M. Aires-Barros,et al. Aqueous two-phase extraction as a platform in the biomanufacturing industry: economical and environmental sustainability. , 2011, Biotechnology advances.
[59] Marc Bisschops,et al. platforms Single-Use , Continuous-Countercurrent , Multicolumn Chromatography , 2009 .
[60] Ana M Azevedo,et al. Continuous purification of antibodies from cell culture supernatant with aqueous two-phase systems: from concept to process. , 2013, Biotechnology journal.
[61] M. Schofield,et al. Transfer of a three step mAb chromatography process from batch to continuous: Optimizing productivity to minimize consumable requirements. , 2017, Journal of biotechnology.
[62] David S. Kahn,et al. Continuous countercurrent tangential chromatography for mixed mode post-capture operations in monoclonal antibody purification. , 2017, Journal of chromatography. A.
[63] Massimo Morbidelli,et al. Perfusion mammalian cell culture for recombinant protein manufacturing - A critical review. , 2018, Biotechnology advances.
[64] Songsong Liu,et al. Designing cost‐effective biopharmaceutical facilities using mixed‐integer optimization , 2013, Biotechnology progress.
[65] Anurag S. Rathore,et al. Non-protein A purification platform for continuous processing of monoclonal antibody therapeutics. , 2018, Journal of chromatography. A.
[66] Alois Jungbauer,et al. Continuous downstream processing of biopharmaceuticals. , 2013, Trends in biotechnology.
[67] Suzanne S Farid,et al. Fed‐batch and perfusion culture processes: Economic, environmental, and operational feasibility under uncertainty , 2013, Biotechnology and bioengineering.
[68] Suzanne S. Farid,et al. Integrated economic and experimental framework for screening of primary recovery technologies for high cell density CHO cultures , 2016, Biotechnology journal.
[69] Suzanne S. Farid,et al. Evaluating the economic and operational feasibility of continuous processes for monoclonal antibodies , 2014 .
[70] Konstantin B Konstantinov,et al. White paper on continuous bioprocessing. May 20-21, 2014 Continuous Manufacturing Symposium. , 2015, Journal of pharmaceutical sciences.
[71] M Angela Taipa,et al. Antibodies and Genetically Engineered Related Molecules: Production and Purification , 2004, Biotechnology progress.
[72] D. Ecker,et al. The therapeutic monoclonal antibody market , 2015, mAbs.
[73] Suzanne S Farid,et al. Process economics of industrial monoclonal antibody manufacture. , 2007, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.
[74] Yao-ming Huang,et al. Perfusion seed cultures improve biopharmaceutical fed‐batch production capacity and product quality , 2014, Biotechnology progress.
[75] Marcos Antonio de Oliveira,et al. Biopharmaceuticals from microorganisms: from production to purification , 2016, Brazilian journal of microbiology : [publication of the Brazilian Society for Microbiology].
[76] S. Dübel,et al. Cell-free synthesis of functional antibodies using a coupled in vitro transcription-translation system based on CHO cell lysates , 2017, Scientific Reports.
[77] M. Aires-Barros,et al. Aqueous two-phase systems: A viable platform in the manufacturing of biopharmaceuticals. , 2010, Journal of chromatography. A.
[78] Joanna Rucker-Pezzini,et al. Single Pass Diafiltration Integrated into a Fully Continuous mAb Purification Process. , 2018, Biotechnology and bioengineering.
[79] Demetri Petrides,et al. Bioprocess Design and Economics , 2003 .
[80] M. Aires-Barros,et al. Continuous aqueous two-phase extraction of human antibodies using a packed column. , 2012, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.
[81] Andrew L. Zydney,et al. Continuous downstream processing for high value biological products: A Review , 2016, Biotechnology and bioengineering.
[82] Alex Xenopoulos,et al. A new, integrated, continuous purification process template for monoclonal antibodies: Process modeling and cost of goods studies. , 2015, Journal of biotechnology.
[83] Martin Lobedann,et al. A Biomanufacturing Facility Based On Continuous Processing And Single Use Technology , 2015 .
[84] A. Spirin,et al. Continuous-Flow and Continuous-Exchange Cell-Free Translation Systems and Reactors , 2002 .
[85] Nigel J. Titchener‐Hooker,et al. Economic analysis of royalactin production under uncertainty: Evaluating the effect of parameter optimization , 2015, Biotechnology progress.
[86] Michael C Jewett,et al. Development of a CHO-Based Cell-Free Platform for Synthesis of Active Monoclonal Antibodies. , 2017, ACS synthetic biology.
[87] Angelo Lucia. Chemical Engineering Design Principles, Practice, and Economics of Plant and Process Design By G. Towler and R. Sinnott , 2008 .
[88] Ye Zhang,et al. Very High Density of CHO Cells in Perfusion by ATF or TFF in WAVE Bioreactor™. Part I. Effect of the Cell Density on the Process , 2013, Biotechnology progress.
[89] Daniar Hussain,et al. Countercurrent tangential chromatography for large‐scale protein purification , 2011, Biotechnology and bioengineering.
[90] Frank Riske,et al. Periodic counter-current chromatography -- design and operational considerations for integrated and continuous purification of proteins. , 2012, Biotechnology journal.
[91] R. Bayer,et al. Recovery and purification process development for monoclonal antibody production , 2010, mAbs.
[92] Lazaros G. Papageorgiou,et al. Multi-objective optimisation for biopharmaceutical manufacturing under uncertainty , 2018, Comput. Chem. Eng..
[93] Massimo Morbidelli,et al. Characterization and comparison of ATF and TFF in stirred bioreactors for continuous mammalian cell culture processes , 2016 .
[94] Jason Walther,et al. The business impact of an integrated continuous biomanufacturing platform for recombinant protein production. , 2015, Journal of biotechnology.
[95] M. Hurme,et al. Economic comparison of diagnostic antibody production in perfusion stirred tank and in hollow fiber bioreactor processes , 2011, Biotechnology progress.
[96] Jochen Strube,et al. Integration of Aqueous Two-Phase Extraction as Cell Harvest and Capture Operation in the Manufacturing Process of Monoclonal Antibodies , 2017, Antibodies.
[97] Marco Rito-Palomares,et al. Process Economics: Evaluation of the Potential of ATPS as a Feasible Alternative to Traditional Fractionation Techniques , 2017 .
[98] Jochen Strube,et al. Multi‐Stage Aqueous Two‐Phase Extraction for the Purification of Monoclonal Antibodies , 2014 .
[99] Karan Sukhija,et al. A Single-use Strategy to Enable Manufacturing of Affordable Biologics , 2016, Computational and structural biotechnology journal.
[100] Ashok Kumar,et al. Upstream processes in antibody production: evaluation of critical parameters. , 2008, Biotechnology advances.
[101] Lawrence X. Yu,et al. Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA's Office of Pharmaceutical Quality. , 2016, International journal of pharmaceutics.
[102] Anurag S. Rathore,et al. Process integration and control in continuous bioprocessing , 2018, Current Opinion in Chemical Engineering.
[103] Rohan Patil,et al. Continuous Manufacturing of Recombinant Therapeutic Proteins: Upstream and Downstream Technologies. , 2018, Advances in biochemical engineering/biotechnology.
[104] Ana M Azevedo,et al. Monoclonal Antibodies Production Platforms: An Opportunity Study of a Non-Protein-A Chromatographic Platform Based on Process Economics. , 2017, Biotechnology journal.
[105] Charles L. Cooney,et al. White Paper on Continuous Bioprocessing , 2014 .
[106] Daniel G. Bracewell,et al. Cell free protein synthesis: a viable option for stratified medicines manufacturing? , 2017 .