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| Author | : Steven J. Shire |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 348 |
| Release | : 2009-11-11 |
| Genre | : Medical |
| ISBN | : 038776643X |
Download Current Trends in Monoclonal Antibody Development and Manufacturing Book in PDF, ePub and Kindle
Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.
| Author | : G. Subramanian |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 260 |
| Release | : 2013-03-07 |
| Genre | : Medical |
| ISBN | : 1441988750 |
Download Antibodies Book in PDF, ePub and Kindle
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 | : William R Strohl |
| Publisher | : Elsevier |
| Total Pages | : 697 |
| Release | : 2012-10-16 |
| Genre | : Medical |
| ISBN | : 1908818093 |
Download Therapeutic Antibody Engineering Book in PDF, ePub and Kindle
The field of antibody engineering has become a vital and integral part of making new, improved next generation therapeutic monoclonal antibodies, of which there are currently more than 300 in clinical trials across several therapeutic areas. Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on future candidates. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. Following chapters cover a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering. Goes beyond the standard engineering issues covered by most books and delves into structure-function relationships Integration of knowledge across all areas of antibody engineering, development, and marketing Discusses how current and future genetic engineering of cell lines will pave the way for much higher productivity
| Author | : Uwe Gottschalk |
| Publisher | : John Wiley & Sons |
| Total Pages | : 752 |
| Release | : 2017-03-07 |
| Genre | : Medical |
| ISBN | : 1119126932 |
Download Process Scale Purification of Antibodies Book in PDF, ePub and Kindle
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 | : National Research Council |
| Publisher | : National Academies Press |
| Total Pages | : 74 |
| Release | : 1999-05-06 |
| Genre | : Medical |
| ISBN | : 0309173051 |
Download Monoclonal Antibody Production Book in PDF, ePub and Kindle
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 | : Ron Hubbard |
| Publisher | : Springer |
| Total Pages | : 258 |
| Release | : 2013-09-13 |
| Genre | : Medical |
| ISBN | : 9781461288619 |
Download Clinical Applications of Monoclonal Antibodies Book in PDF, ePub and Kindle
Immunology has come a long way in the hundred or so years since the general concepts were first enuciated by Metchnikoff, Ehrlich, Von Bebring and others, One of the landmarks in this progress was the invention and development of monoclonal antibody secreting hybridomas by Milstein and bis co-workers in Cambridge. Unlike most modern inventions of this importance that of monoclonal antibody production was made available to the scientific community tbroughout the world unimpeded by patent protection. This may explain tbe unusual rapidity witb which it has been applied to the benefit of mankind in general. This book, representing as it does the proceedings of tbe first International Symposium to be held on the clinical appli cations of monoclonal antibodies, shows just how much bas been achieved within the space of little more than a decade. The enormaus promise of monoclonal antibody technology, which became apparent soon after its discovery, has already progressed a long way towards fulfillment. The contributors to tbis volume, all of whom are actively engaged in monoclonal antibody development and application, represent the state of the art. Professor Vincent Marks V INTRODUCTION It has been some twelve years since the pioneering experiments of Köhler and Milstein led to the discovery of monoclonal antibodies. Single molecular species antiborlies with desired specificities could be produced by the fusion of antibody - producing cells with neoplastic cells.
| Author | : Bob Kiss |
| Publisher | : Springer |
| Total Pages | : 473 |
| Release | : 2018-12-06 |
| Genre | : Science |
| ISBN | : 3319971107 |
Download New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins Book in PDF, ePub and Kindle
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 | : Stewart Sell |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 440 |
| Release | : 2012-12-06 |
| Genre | : Medical |
| ISBN | : 1461251761 |
Download Monoclonal Antibodies in Cancer Book in PDF, ePub and Kindle
This represents the third volume in a series on cancer markers pub lished by the Humana Press. The first volume, published in 1980, stressed the relationship of development and cancer as reflected in the production of markers by cancer that are also produced by normal cells during fetal development. The concept that cancer represents a problem of differentiation was introduced by Barry Pierce in describing differenti ation of teratocarcinomas. Highlighted were lymphocyte markers, alphafetoprotein, carcinoembryonic antigen, ectopic hormones, enzymes and isozymes, pregnancy proteins, and fibronectin. The second volume, published in 1982 and coedited with Britta Wahren, focused on the diagnostic use of oncological markers in human cancers, which were systematically treated on an organ by organ basis. At that time, the application of monoclonal antibodies to the identification of cancer markers was still in a very preliminary stage. A general introduc tion to monoclonal antibodies to human tumor antigens was given there by William Raschke, and other authors included coverage of those mark ers then detectable by monoclonal antibodies in their chapters.
| Author | : Ganapathy Subramanian |
| Publisher | : John Wiley & Sons |
| Total Pages | : 404 |
| Release | : 2021-12-15 |
| Genre | : Technology & Engineering |
| ISBN | : 3527827331 |
Download Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing Book in PDF, ePub and Kindle
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.
| Author | : John E. Schiel |
| Publisher | : ACS Symposium |
| Total Pages | : 0 |
| Release | : 2016-06-24 |
| Genre | : Medical |
| ISBN | : 9780841230293 |
Download State-Of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization Book in PDF, ePub and Kindle
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