Process Scale Purification Of Antibodies

Author : Uwe Gottschalk
Publisher : John Wiley & Sons
Page : 752 pages
File Size : 42,6 Mb
Release : 2017-03-07
Category : Medical
ISBN : 9781119126935

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Process Scale Purification of Antibodies by Uwe Gottschalk Pdf

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

Author : Uwe Gottschalk
Publisher : John Wiley & Sons
Page : 344 pages
File Size : 42,5 Mb
Release : 2011-09-20
Category : Medical
ISBN : 9781118210741

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Process Scale Purification of Antibodies by Uwe Gottschalk Pdf

Traditional column chromatography dominates current purification technology, and many of the productivity gains that have been achieved have relied on upscaling such devices. However, this comes with a cost penalty and the pharmaceutical industry has reached the point at which further upscaling becomes economically unsupportable. This book offers a broad-based reassessment of old and new purification methods, incorporating an analysis of innovative new trends in purification. The book has wide coverage of different antibody purification strategies and brings together top-tier experts to address problems in process-scale antibody purification.

Author : Uwe Gottschalk
Publisher : John Wiley & Sons
Page : 754 pages
File Size : 46,8 Mb
Release : 2017-04-03
Category : Medical
ISBN : 9781119126911

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Process Scale Purification of Antibodies by Uwe Gottschalk Pdf

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

Author : Allan Matte
Publisher : Elsevier
Page : 222 pages
File Size : 55,9 Mb
Release : 2020-09-07
Category : Business & Economics
ISBN : 9780081030196

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

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

Author : G. Subramanian
Publisher : Springer Science & Business Media
Page : 352 pages
File Size : 41,8 Mb
Release : 2013-03-07
Category : Medical
ISBN : 9781441988751

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Antibodies by G. Subramanian Pdf

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.

Author : National Research Council,Institute for Laboratory Animal Research,Committee on Methods of Producing Monoclonal Antibodies
Publisher : National Academies Press
Page : 74 pages
File Size : 52,9 Mb
Release : 1999-05-06
Category : Medical
ISBN : 9780309173056

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Monoclonal Antibody Production by National Research Council,Institute for Laboratory Animal Research,Committee on Methods of Producing Monoclonal Antibodies Pdf

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.

Author : Pete Gagnon
Publisher : Validated Biosystems Incorporated
Page : 278 pages
File Size : 48,9 Mb
Release : 1996
Category : Medical
ISBN : UOM:39015038607951

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Purification Tools for Monoclonal Antibodies by Pete Gagnon Pdf

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.

Author : Abhinav A. Shukla,Mark R. Etzel,Shishir Gadam
Publisher : CRC Press
Page : 600 pages
File Size : 41,8 Mb
Release : 2006-07-07
Category : Medical
ISBN : 9781420016024

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Process Scale Bioseparations for the Biopharmaceutical Industry by Abhinav A. Shukla,Mark R. Etzel,Shishir Gadam Pdf

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

Author : Theodore H. Meltzer,Maik W. Jornitz
Publisher : CRC Press
Page : 950 pages
File Size : 41,6 Mb
Release : 1998-01-05
Category : Medical
ISBN : 0824798961

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Filtration in the Biopharmaceutical Industry by Theodore H. Meltzer,Maik W. Jornitz Pdf

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.

Author : Allan Matte
Publisher : Elsevier
Page : 224 pages
File Size : 41,9 Mb
Release : 2020-08-20
Category : Business & Economics
ISBN : 9780128186572

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

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

Author : Michael Steinitz
Publisher : Humana Press
Page : 0 pages
File Size : 52,7 Mb
Release : 2013-09-14
Category : Medical
ISBN : 1627035850

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Human Monoclonal Antibodies by Michael Steinitz Pdf

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.

Author : Bob Kiss,Uwe Gottschalk,Michael Pohlscheidt
Publisher : Springer
Page : 473 pages
File Size : 42,8 Mb
Release : 2018-12-06
Category : Science
ISBN : 9783319971100

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New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins by Bob Kiss,Uwe Gottschalk,Michael Pohlscheidt Pdf

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.

Author : Ganapathy Subramanian
Publisher : John Wiley & Sons
Page : 528 pages
File Size : 47,9 Mb
Release : 2015-02-09
Category : Medical
ISBN : 9783527335954

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Continuous Processing in Pharmaceutical Manufacturing by Ganapathy Subramanian Pdf

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.

Author : Gunter Jagschies,Gail K. Sofer,Lars Hagel
Publisher : Elsevier
Page : 382 pages
File Size : 41,7 Mb
Release : 2007-12-08
Category : Science
ISBN : 0080554512

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Handbook of Process Chromatography by Gunter Jagschies,Gail K. Sofer,Lars Hagel Pdf

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

Author : Sally S. Seaver
Publisher : Marcel Dekker
Page : 360 pages
File Size : 40,6 Mb
Release : 1987
Category : Biochemical engineering
ISBN : UOM:39015015128872

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Commercial Production of Monoclonal Antibodies by Sally S. Seaver Pdf