Process Scale Bioseparations For The Biopharmaceutical Industry
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Process Scale Bioseparations For The Biopharmaceutical Industry
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Author : Abhinav A. Shukla
language : en
Publisher: CRC Press
Release Date : 2006-07-07
Process Scale Bioseparations For The Biopharmaceutical Industry written by Abhinav A. Shukla and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-07-07 with Medical categories.
The biopharmaceutical industry has become an increasingly important player in the global economy, and the success of these products depends on the development and implementation of cost-effective, robust and scaleable production processes. Bioseparations-also called downstream processing- can be a key source of competitive advantageto biopharmaceut
Protein Chromatography
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Author : Giorgio Carta
language : en
Publisher: John Wiley & Sons
Release Date : 2020-06-02
Protein Chromatography written by Giorgio Carta and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-06-02 with Science categories.
An all-in-one practical guide on how to efficiently use chromatographic separation methods Based on a training course that teaches the theoretical as well as practical aspects of protein bioseparation to bioprocess professionals, this fully updated and revised new edition offers comprehensive coverage of continuous chromatography and provides readers with many relevant examples from the biopharmaceutical industry. Divided into two large parts, Protein Chromatography: Process Development and Scale-Up, Second Edition presents all the necessary knowledge for effective process development in chromatographic bioseparation, both on small and large scale. The first part introduces chromatographic theory, including process design principles, to enable the reader to rationalize the set-up of a bioseparation process. The second part illustrates by way of case studies and sample protocols how the theory learned in the first part may be applied to real-life problems. Chapters look at: Downstream Processing of Biotechnology Products; Chromatography Media; Laboratory and Process Columns and Equipment; Adsorption Equilibrium; Rate Processes; and Dynamics of Chromatography Columns. The book closes with chapters on: Effects of Dispersion and Rate Processes on Column Performance; Gradient Elution Chromatography; and Chromatographic Column Design and Optimization. -Presents the most pertinent examples from the biopharmaceutical industry, including monoclonal antibodies -Provides an overview of the field along with design tools and examples illustrating the advantages of continuous processing in biopharmaceutical productions -Focuses on process development and large-scale bioseparation tasks, making it an ideal guide for the professional bioengineer in the biotech and pharma industries -Offers field-tested information based on decades of training courses for biotech and chemical engineers in Europe and the U.S. Protein Chromatography: Process Development and Scale-Up, Second Edition will appeal to biotechnologists, analytical chemists, chromatographers, chemical engineers, pharmaceutical industry, biotechnological industry, and biochemists.
Biopharmaceutical Processing
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Author : Gunter Jagschies
language : en
Publisher: Elsevier
Release Date : 2018-01-18
Biopharmaceutical Processing written by Gunter Jagschies and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-01-18 with Technology & Engineering categories.
Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. Offers a comprehensive, go-to reference for daily work decisions Covers both upstream and downstream processes Includes case studies that emphasize financial outcomes Presents summaries, decision grids, graphs and overviews for quick reference
Process Validation In Manufacturing Of Biopharmaceuticals
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Author : Anurag S. Rathore
language : en
Publisher: CRC Press
Release Date : 2012-05-09
Process Validation In Manufacturing Of Biopharmaceuticals written by Anurag S. Rathore and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-05-09 with Medical categories.
Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in
Process Scale Purification Of Antibodies
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Author : Uwe Gottschalk
language : en
Publisher: John Wiley & Sons
Release Date : 2017-03-07
Process Scale Purification Of Antibodies written by Uwe Gottschalk and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-03-07 with Medical categories.
Promoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification. • Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing • Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification • Emphasizes antibodies and innovative chromatography methods for processing
Continuous Biomanufacturing
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Author : Ganapathy Subramanian
language : en
Publisher: John Wiley & Sons
Release Date : 2017-09-12
Continuous Biomanufacturing written by Ganapathy Subramanian and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-12 with Science categories.
This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.
Bioseparations
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Author : Paul A. Belter
language : en
Publisher: Wiley-Interscience
Release Date : 1988-02-22
Bioseparations written by Paul A. Belter and has been published by Wiley-Interscience this book supported file pdf, txt, epub, kindle and other format this book has been release on 1988-02-22 with Science categories.
Offers a concise introduction to the separation and purification of biochemicals. Bridges two scientific cultures, providing an introduction to bioseparations for scientists with no background in engineering and for engineers with little grounding in biology. The authors supplement the ideas by simple worked examples, making the techniques of bioseparations easy to learn. Discusses removal of insolubles, product isolation, purification and polishing.
Handbook Of Bioseparations
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Author : Satinder Ahuja
language : en
Publisher: Elsevier
Release Date : 2000-06-23
Handbook Of Bioseparations written by Satinder Ahuja and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000-06-23 with Technology & Engineering categories.
It is generally recognized that the commercial success of biotechnology products is highly dependent on the successful development and application of high-powered separation and purification methods. In this practical and authoritative handbook, the separation of proteins, nucleic acids, and oligonucleotides from biological matrices is covered from analytical to process scales. Also included in a chapter on the separation of monoclonal antibodies, which have found numerous uses as therapeutic and diagnostic agents. Analytical techniques include an interesting montage of chromatographic methods, capillary electrophoresis, isoelectric focusing, and mass spectrometry. Among separation and purification methods, liquid-liquid distribution, displacement chromatography, expanded bed adsorption, membrane chromatography, and simulated moving bed chromatography are covered at length. Regulatory and economic considerations are addressed, as are plant and process equipment and engineering process control. A chapter on future developments highlights the application of DNA chip arrays as well as evolving methodologies for a large number of drugs that are under development for treatment of cancer, AIDS, rheumatoid arthritis, and Alzheimer's disease. Handbook of Bioseparations serves as an essential reference and guidebook for separation scientists working in the pharmaceutical and biotechnology industries, academia, and government laboratories. Key Features * Covers bioseparations of proteins, nucleic acids, and monoclonal antibodies * Encompasses both analytical and process-scale methods * Elucidates the importance of engineering process control * Details selection of plant and process equipment * Addresses economic considerations * Discusses future developments
Pat Applied In Biopharmaceutical Process Development And Manufacturing
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Author : Cenk Undey
language : en
Publisher: CRC Press
Release Date : 2011-12-07
Pat Applied In Biopharmaceutical Process Development And Manufacturing written by Cenk Undey and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-12-07 with Medical categories.
As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the comp
Antibody Expression And Production
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Author : Mohamed Al-Rubeai
language : en
Publisher: Springer Science & Business Media
Release Date : 2011-05-16
Antibody Expression And Production written by Mohamed Al-Rubeai and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-05-16 with Medical categories.
Engineered antibodies currently represent over 30% of biopharmaceuticals in clinical trials and their total worldwide sales continue to increase significantly. The importance of antibody applications is reflected in their increasing clinical and industrial applications as well as in the progression of established and emerging production strategies. This volume provides detailed coverage of the generation, optimization, characterization, production and applications of antibody. It provides the necessary theoretical background and description of methods for the expression of antibody in microbial and animal cell cultures and in transgenic animals and plants. There is a strong focus on those issues related to the production of intrabodies, bispecific antibody and antibody fragments and also to novel applications in cancer immunotherapy.