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Process Scale Purification of Antibodies

Author : Uwe Gottschalk

Publisher : John Wiley & Sons

Page : 849 pages

File Size : 22,69 MB

Release : 2017-03-07

Category : Medical

ISBN : 1119126932

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Book Description

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

Page : 344 pages

File Size : 36,74 MB

Release : 2011-09-20

Category : Medical

ISBN : 1118210743

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Book Description

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.



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

Author : Allan Matte

Publisher : Elsevier

Page : 222 pages

File Size : 46,11 MB

Release : 2020-09-07

Category : Business & Economics

ISBN : 0081030193

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Book Description

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



Purification Tools for Monoclonal Antibodies

Author : Pete Gagnon

Publisher : Validated Biosystems Incorporated

Page : 278 pages

File Size : 26,7 MB

Release : 1996

Category : Medical

ISBN :

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Book Description

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.



Monoclonal Antibody Production

Author : National Research Council

Publisher : National Academies Press

Page : 74 pages

File Size : 27,89 MB

Release : 1999-05-06

Category : Medical

ISBN : 0309173051

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Book Description

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.



Preparative Chromatography for Separation of Proteins

Author : Arne Staby

Publisher : John Wiley & Sons

Page : 608 pages

File Size : 40,46 MB

Release : 2017-02-02

Category : Technology & Engineering

ISBN : 1119031176

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Book Description

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

Page : 600 pages

File Size : 40,60 MB

Release : 2006-07-07

Category : Medical

ISBN : 1420016024

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Book Description

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

Page : 404 pages

File Size : 18,96 MB

Release : 2021-12-20

Category : Technology & Engineering

ISBN : 3527347690

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Book Description

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.



Protein Chromatography

Author : Giorgio Carta

Publisher : John Wiley & Sons

Page : 440 pages

File Size : 31,71 MB

Release : 2020-06-02

Category : Science

ISBN : 352734666X

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Book Description

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.



Flow Cytometry

Author : Alice Longobardi Givan

Publisher : John Wiley & Sons

Page : 309 pages

File Size : 44,12 MB

Release : 2013-04-10

Category : Science

ISBN : 1118688392

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Book Description

Flow cytometry continually amazes scientists with its ever-expanding utility. Advances in flow cytometry have opened new directions in theoretical science, clinical diagnosis, and medical practice. The new edition of Flow Cytometry: First Principles provides a thorough update of this now classic text, reflecting innovations in the field while outlining the fundamental elements of instrumentation, sample preparation, and data analysis. Flow Cytometry: First Principles, Second Edition explains the basic principles of flow cytometry, surveying its primary scientific and clinical applications and highlighting state-of-the-art techniques at the frontiers of research. This edition contains extensive revisions of all chapters, including new discussions on fluorochrome and laser options for multicolor analysis, an additionalsection on apoptosis in the chapter on DNA, and new chapters onintracellular protein staining and cell sorting, including high-speed sorting and alternative sorting methods, as well as traditional technology. This essential resource: Assumes no prior knowledge of flow cytometry Progresses with an informal, engaging lecture style from simpleto more complex concepts Offers a clear introduction to new vocabulary, principles of instrumentation, and strategies for data analysis Emphasizes the theory relevant to all flow cytometry, with examples from a variety of clinical and scientific fields Flow Cytometry: First Principles, Second Edition provides scientists, clinicians, technologists, and students with the knowledge necessary for beginning the practice of flow cytometry and for understanding related literature.