Process Scale Purification Of Antibodies

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Process Scale Purification of Antibodies

Author : Uwe Gottschalk
Publisher : John Wiley & Sons
ISBN 13 : 1119126932
Total Pages : 752 pages
Book Rating : 4.1/5 (191 download)

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Book Synopsis Process Scale Purification of Antibodies by : Uwe Gottschalk

Download or read book Process Scale Purification of Antibodies written by Uwe Gottschalk and published by John Wiley & Sons. This book was released on 2017-03-07 with total page 752 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Process Scale Purification of Antibodies

Author : Uwe Gottschalk
Publisher : John Wiley & Sons
ISBN 13 : 1119126916
Total Pages : 754 pages
Book Rating : 4.1/5 (191 download)

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Book Synopsis Process Scale Purification of Antibodies by : Uwe Gottschalk

Download or read book Process Scale Purification of Antibodies written by Uwe Gottschalk and published by John Wiley & Sons. This book was released on 2017-04-03 with total page 754 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics

Author : Allan Matte
Publisher : Elsevier
ISBN 13 : 0081030193
Total Pages : 222 pages
Book Rating : 4.0/5 (81 download)

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Book Synopsis Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics by : Allan Matte

Download or read book Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics written by Allan Matte and published by Elsevier. This book was released on 2020-09-07 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics provides the interested and informed reader with an overview of current approaches, strategies and considerations relating to the purification, analytics and characterization of therapeutic antibodies and related molecules. While there are obviously other books published in and around this subject area, they seem to be either older (c.a. year 2000 publication date) or are more limited in scope. The book will include an extensive bibliography of the published literature in the respective areas covered. It is not, however, intended to be a how-to methods book. Covers the vital new area of R&D on therapeutic antibodies Written by leading scientists and researchers Up-to-date coverage and includes a detailed bibliography

Monoclonal Antibody Production

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309064473
Total Pages : 74 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Monoclonal Antibody Production by : National Research Council

Download or read book Monoclonal Antibody Production written by National Research Council and published by National Academies Press. This book was released on 1999-06-06 with total page 74 pages. Available in PDF, EPUB and Kindle. Book excerpt: The American Anti-Vivisection Society (AAVS) petitioned the National Institutes of Health (NIH) on April 23, 1997, to prohibit the use of animals in the production of mAb. On September 18, 1997, NIH declined to prohibit the use of mice in mAb production, stating that "the ascites method of mAb production is scientifically appropriate for some research projects and cannot be replaced." On March 26, 1998, AAVS submitted a second petition, stating that "NIH failed to provide valid scientific reasons for not supporting a proposed ban." The office of the NIH director asked the National Research Council to conduct a study of methods of producing mAb. In response to that request, the Research Council appointed the Committee on Methods of Producing Monoclonal Antibodies, to act on behalf of the Institute for Laboratory Animal Research of the Commission on Life Sciences, to conduct the study. The 11 expert members of the committee had extensive experience in biomedical research, laboratory animal medicine, animal welfare, pain research, and patient advocacy (Appendix B). The committee was asked to determine whether there was a scientific necessity for the mouse ascites method; if so, whether the method caused pain or distress; and, if so, what could be done to minimize the pain or distress. The committee was also asked to comment on available in vitro methods; to suggest what acceptable scientific rationale, if any, there was for using the mouse ascites method; and to identify regulatory requirements for the continued use of the mouse ascites method. The committee held an open data-gathering meeting during which its members summarized data bearing on those questions. A 1-day workshop (Appendix A) was attended by 34 participants, 14 of whom made formal presentations. A second meeting was held to finalize the report. The present report was written on the basis of information in the literature and information presented at the meeting and the workshop.

Antibodies

Author : G. Subramanian
Publisher : Springer Science & Business Media
ISBN 13 : 1441988750
Total Pages : 352 pages
Book Rating : 4.4/5 (419 download)

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Book Synopsis Antibodies by : G. Subramanian

Download or read book Antibodies written by G. Subramanian and published by Springer Science & Business Media. This book was released on 2013-03-07 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: If the antibody industry is to achieve its full potential in the next decade, the individual technical potentials must be exploited, the limitations must be addressed, and lessons learned must be applied both to current purification methods and to the new technologies that continue to emerge. This book presents an overview of the current advances applied in the manufacture of monoclonal antibody including: -concepts in development of manufacturing strategies, -importance of antibody fragments, -application of chromatography method development, -quality control, -effect of expression on antibody properties, -virus removal and safety, -pharmacokinetics, -regulatory aspects.

Purification Tools for Monoclonal Antibodies

Author : Pete Gagnon
Publisher : Validated Biosystems Incorporated
ISBN 13 :
Total Pages : 278 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Purification Tools for Monoclonal Antibodies by : Pete Gagnon

Download or read book Purification Tools for Monoclonal Antibodies written by Pete Gagnon and published by Validated Biosystems Incorporated. This book was released on 1996 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: Purification Tools for Monoclonal is an essential book for professionals, educators and advanced students in the field of Biotechnology. It is based on experience gained from purification process development, scale-up, and manufacture of more than 250 monoclonal-based diagnostic and therapeutic products. Ten chapters provide in-depth coverage of major separation mechanisms, process strengths, weaknesses and method development; all fully integrated with the special performance, economic and validation requirements associated with monoclonals. Covered methods include precipitation with inorganic salts, polyethylene glycol, electrolyte depletion, caprylic acid, ethacridine, chromatographic purification by size exclusion, ion exchange, hydroxyapatite, hydrophobic interaction, immobilized metal affinity, hydrophilic interaction, euglobulin adsorption, thiophilic adsorption, protein A, protein G, lectin affinity, and more. 88 figures, 29 tables.

Preparative Chromatography for Separation of Proteins

Author : Arne Staby
Publisher : John Wiley & Sons
ISBN 13 : 1119031176
Total Pages : 608 pages
Book Rating : 4.1/5 (19 download)

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Book Synopsis Preparative Chromatography for Separation of Proteins by : Arne Staby

Download or read book Preparative Chromatography for Separation of Proteins written by Arne Staby and published by John Wiley & Sons. This book was released on 2017-02-02 with total page 608 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preparative Chromatography for Separation of Proteins addresses a wide range of modeling, techniques, strategies, and case studies of industrial separation of proteins and peptides. • Covers broad aspects of preparative chromatography with a unique combination of academic and industrial perspectives • Presents Combines modeling with compliantce useing of Quality-by-Design (QbD) approaches including modeling • Features a variety of chromatographic case studies not readily accessible to the general public • Represents an essential reference resource for academic, industrial, and pharmaceutical researchers

Process Scale Bioseparations for the Biopharmaceutical Industry

Author : Abhinav A. Shukla
Publisher : CRC Press
ISBN 13 : 1420016024
Total Pages : 600 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Process Scale Bioseparations for the Biopharmaceutical Industry by : Abhinav A. Shukla

Download or read book Process Scale Bioseparations for the Biopharmaceutical Industry written by Abhinav A. Shukla and published by CRC Press. This book was released on 2006-07-07 with total page 600 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing

Author : Ganapathy Subramanian
Publisher : John Wiley & Sons
ISBN 13 : 3527827331
Total Pages : 404 pages
Book Rating : 4.5/5 (278 download)

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Book Synopsis Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing by : Ganapathy Subramanian

Download or read book Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2021-12-15 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing Explore new trends in continuous biomanufacturing with contributions from leading practitioners in the field With the increasingly widespread acceptance and investment in the ??technology, the last decade has demonstrated the utility of continuous ??processing in the pharmaceutical industry. In Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing, distinguished biotechnologist Dr. Ganapathy Subramanian delivers a comprehensive exploration of the potential of the continuous processing of biological products and discussions of future directions in advancing continuous processing to meet new challenges and demands in the manufacture of therapeutic products. A stand-alone follow-up to the editor’s Continuous Biomanufacturing: Innovative Technologies and Methods published in 2017, this new edited volume focuses on critical aspects of process intensification, process control, and the digital transformation of biopharmaceutical processes. In addition to topics like the use of multivariant data analysis, regulatory concerns, and automation processes, the book also includes: Thorough introductions to capacitance sensors to control feeding strategies and the continuous production of viral vaccines Comprehensive explorations of strategies for the continuous upstream processing of induced microbial systems Practical discussions of preparative hydrophobic interaction chromatography and the design of modern protein-A-resins for continuous biomanufacturing In-depth examinations of bioprocess intensification approaches and the benefits of single use for process intensification Perfect for biotechnologists, bioengineers, pharmaceutical engineers, and process engineers, Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing is also an indispensable resource for chemical engineers seeking a one-stop reference on continuous biomanufacturing.

Human Monoclonal Antibodies

Author : Michael Steinitz
Publisher : Humana Press
ISBN 13 : 9781627035859
Total Pages : 0 pages
Book Rating : 4.0/5 (358 download)

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Book Synopsis Human Monoclonal Antibodies by : Michael Steinitz

Download or read book Human Monoclonal Antibodies written by Michael Steinitz and published by Humana Press. This book was released on 2013-09-14 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The introduction of monoclonal antibodies revolutionized immunology. The development of human monoclonal antibodies was inspired primarily by the enormous clinical benefits promised by these reagents which can be used as anti-inflammatory reagents, anti-tumor reagents and reagents for passive immunization in a variety of pathologies. Human Monoclonal Antibodies: Methods and Protocols presents technical protocols of cellular and molecular methods for the production, purification and application of human monoclonal antibodies, as well as review articles on related topics of human monoclonal and polyclonal antibodies. Written in the successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible protocols, and notes on troubleshooting and avoiding known pitfalls. Authoritative and easily accessible, Human Monoclonal Antibodies: Methods and Protocols seeks to serve both professionals and novices with its well-honed methodologies which will prove invaluable in a clinical setting.

Protein Chromatography

Author : Giorgio Carta
Publisher : John Wiley & Sons
ISBN 13 : 352734666X
Total Pages : 440 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Protein Chromatography by : Giorgio Carta

Download or read book Protein Chromatography written by Giorgio Carta and published by John Wiley & Sons. This book was released on 2020-06-02 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Single-Use Technology in Biopharmaceutical Manufacture

Author : Regine Eibl
Publisher : John Wiley & Sons
ISBN 13 : 1119477778
Total Pages : 672 pages
Book Rating : 4.1/5 (194 download)

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Book Synopsis Single-Use Technology in Biopharmaceutical Manufacture by : Regine Eibl

Download or read book Single-Use Technology in Biopharmaceutical Manufacture written by Regine Eibl and published by John Wiley & Sons. This book was released on 2019-07-24 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.

Therapeutic Antibodies

Author : Gunnar Houen
Publisher : Humana
ISBN 13 : 9781071614525
Total Pages : 0 pages
Book Rating : 4.6/5 (145 download)

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Book Synopsis Therapeutic Antibodies by : Gunnar Houen

Download or read book Therapeutic Antibodies written by Gunnar Houen and published by Humana. This book was released on 2022-09-18 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This detailed book covers methods for studying, producing, and analyzing therapeutic antibodies, measuring their concentration, developing neutralizing antibodies for them, and for predicting and monitoring their therapeutic efficacy and clinical effects. These biologics are the fastest growing pharmaceutical drug group and have had tremendous clinical and scientific impact in cancer, autoimmune diseases, infectious diseases, and other immune-related diseases, making the content of this volume essential. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible methods, and tips on troubleshooting and avoiding known pitfalls. Authoritative and practical, Therapeutic Antibodies: Methods and Protocols serves as an ideal guide for researchers working with the production of, research on, and development of therapeutic antibodies as well as for clinicians using therapeutic antibodies in daily work with patients.

Continuous Processing in Pharmaceutical Manufacturing

Author : Ganapathy Subramanian
Publisher : John Wiley & Sons
ISBN 13 : 3527335951
Total Pages : 528 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Continuous Processing in Pharmaceutical Manufacturing by : Ganapathy Subramanian

Download or read book Continuous Processing in Pharmaceutical Manufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2015-02-09 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.

Filtration in the Biopharmaceutical Industry

Author : Theodore H. Meltzer
Publisher : CRC Press
ISBN 13 : 9780824798963
Total Pages : 950 pages
Book Rating : 4.7/5 (989 download)

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Book Synopsis Filtration in the Biopharmaceutical Industry by : Theodore H. Meltzer

Download or read book Filtration in the Biopharmaceutical Industry written by Theodore H. Meltzer and published by CRC Press. This book was released on 1998-01-05 with total page 950 pages. Available in PDF, EPUB and Kindle. Book excerpt: Offering a comprehensive examination of developments in the field, this book delineates filtration in a host of applications. Addressing quality, security, economic, process development, and regulatory topics, the book covers pre- and sterility grade filters, charge-modified filter media, and aids to filtration, discusses filter quality assurance, pore size, extractables, and compatibilities in various filters, examines filter design and construction, analyzes integrity testing, test sensitivity, and automation, furnishes novel filtration flow methods, explains filter validation, summarizes the U.S. Food and Drug Administration regulations governing filtration, and more.

New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins

Author : Bob Kiss
Publisher : Springer
ISBN 13 : 3319971107
Total Pages : 473 pages
Book Rating : 4.3/5 (199 download)

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Book Synopsis New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins by : Bob Kiss

Download or read book New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins written by Bob Kiss and published by Springer. This book was released on 2018-12-06 with total page 473 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book review series presents current trends in modern biotechnology. The aim is to cover all aspects of this interdisciplinary technology where knowledge, methods and expertise are required from chemistry, biochemistry, microbiology, genetics, chemical engineering and computer science. Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. The series also discusses new discoveries and applications. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification. In general, special volumes are edited by well-known guest editors. The series editor and publisher will however always be pleased to receive suggestions and supplementary information. Manuscripts are accepted in English.

Handbook of Process Chromatography

Author : Gunter Jagschies
Publisher : Elsevier
ISBN 13 : 9780080554518
Total Pages : 382 pages
Book Rating : 4.5/5 (545 download)

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Book Synopsis Handbook of Process Chromatography by : Gunter Jagschies

Download or read book Handbook of Process Chromatography written by Gunter Jagschies and published by Elsevier. This book was released on 2007-12-08 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers. Updates include: - sources and productivity - types of products made today - experiences in clinical and licensed products - economics - current status of validation - illustrations and tables - automated column packing - automated systems New topics include: - the use of disposables - multiproduct versus dedicated production - design principles for chromatography media and filters - ultrafiltration principles and optimization - risk assessments - characterization studies - design space - platform technologies - process analytical technologies (PATs) - biogenerics - comparability assessments Key Features: - new approaches to process optimiaztion - use of patform technologies - applying risk assessment to process design