Download or read book Monoclonal Antibody Production written by National Research Council and published by National Academies Press. This book was released on 1999-05-06 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.

Download or read book Biosimilars of Monoclonal Antibodies written by Cheng Liu and published by John Wiley & Sons. This book was released on 2016-12-09 with total page 723 pages. Available in PDF, EPUB and Kindle. Book excerpt: Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing. • Guides readers through the complex landscape involved with developing biosimilar versions of monoclonal antibody (mAb) drugs • Features flow charts, tables, and figures that clearly illustrate processes and makes the book comprehensible and accessible • Includes a review of FDA-approved mAb drugs as a quick reference to facts and useful information • Examines new technologies and strategies for improving biosimilar mAbs

Download or read book Molecular Biology of the Cell written by and published by . This book was released on 2002 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Therapeutic Antibody Engineering written by William R Strohl and published by Elsevier. This book was released on 2012-10-16 with total page 697 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Monoclonal Antibodies in Biotechnology written by Kenneth C. McCullough and published by Cambridge University Press. This book was released on 2009-03-19 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume provides a complete description of the principles, methodologies and applications of monoclonal antibodies, one of the most exciting developments to occur in biotechnology in recent years, and a powerful technology for modern industry and science. The immune system and the role of the antibody are described and full details are given on how the hybridomas are formed, isolated, and maintained in culture such that the required antibody can be produced to a high degree of purity. The authors describe all the methodologies involved, all the reagents and solutions and all the assay conditions required for their production. The material is presented to enable research and development managers to make choices as to which are the most suitable techniques for their requirements. The book is comprehensively referenced, and will be a necessary resource for all those who are involved with this technology.

Download or read book Methods of Hybridoma Formation written by Arie H. Bartal and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt: Laymen often consider modern laboratory research to be based on an endless array of sophisticated technologies whose complex capabilities are as important to the outcome of any project as the inventiveness and creativity of the scientists who employ them. Scientists at times may share this point of view until they are con fronted by unexpected findings that demand new approaches, and they discover that yesterday's "sophisticated tools" are today's "blunt instruments." This experience provides a more sobering view of the current state of our scientific methods. It also serves as an impetus for the further development of technology that prepares us for the next stage of advance. Immunologists were confronted by such a technological crises in the late 1970s when they finally were forced to admit that poly clonal antibodies, although quite sensitive reagents, were not spe cific enough to answer many of the questions then confronting virologists and tumor biologists. The answer to the need for specific ity came with the development of monoclonal antibody technology. In the last ten years there have been considerable advances in monoclonal antibody techniques. Today these reagents are much more versatile than they were initially and can be applied to a broad range of problems. Still, most workers who are using these anti bodies are convinced that their potential is far from exhausted, and that at least in some fields we are currently in the early stages of learning how to use them properly.

Download or read book Naturally Occurring Antibodies NAbs written by Hans U. Lutz and published by Springer Science & Business Media. This book was released on 2012-08-19 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume illustrates the functional properties of NAbs. Authors from pioneering groups report in their chapters on the tissue homeostatic, tissue regenerating and regulatory properties of NAbs and NAbs in pooled human IgG. Scientists interested in the regulation and modulation of components of the immune system found a whole variety of NAbs to cytokines with regulatory and protective functions and NAbs that modulate, e.g., dendritic cells, regulatory T cells, B cells and granulocytes. Considering the large plasma pools and initial difficulties in preparing IVIG that does not induce adverse effects upon infusion into recipients, this volume ends with a historical chapter on how pooled human plasma was fractionated and the IgG component pretreated for a safe intravenous application.

Download or read book Cancer Cell Lines Part 1 written by John Masters and published by Springer Science & Business Media. This book was released on 2006-04-11 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: Continuous cell lines derived from human cancers are the most widely used resource in laboratory-based cancer research. The first 3 volumes of this series on Human Cell Culture are devoted to these cancer cell lines. The chapters in these first 3 volumes have a common aim. Their purpose is to address 3 questions of fundamental importance to the relevance of human cancer cell lines as model systems of each type of cancer: 1. Do the cell lines available accurately represent the clinical presentation? 2. Do the cell lines accurately represent the histopathology of the original tumors? 3. Do the cell lines accurately represent the molecular genetics of this type of cancer? The cancer cell lines available are derived, in most cases, from the more aggressive and advanced cancers. There are few cell lines derived from low grade organ-confined cancers. This gap can be filled with conditionally immortalized human cancer cell lines. We do not know why the success rate for establishing cell lines is so low for some types of cancer and so high for others. The histopathology of the tumor of origin and the extent to which the derived cell line retains the differentiated features of that tumor are critical. The concept that a single cell line derived from a tumor at a particular site is representative of tumors at that site is naïve and misleading.

Download or read book Safety of Biologics Therapy written by Brian A. Baldo and published by Springer. This book was released on 2016-08-12 with total page 623 pages. Available in PDF, EPUB and Kindle. Book excerpt: This long overdue title provides a comprehensive, up-to-date, state-of-the art review of approved biologic therapies, with coverage of mechanisms of action, Indications for therapy, immunogenicity and a detailed examination of adverse effects and safety of the many and diverse therapeutic agents presented in a total of 13 chapters. It is predicted that by 2016, biologics will make up half of the world's 20 top-selling drugs and by 2018, biologic medicine sales will account for almost half of the world's 100 biggest selling drugs. Recombinant proteins dominate the growing list of the more than 200 approved biotherapeutic agents with targeted antibodies, fusion proteins and receptors; cytokines; hormones; enzymes; proteins involved in blood-clotting, homeostasis and thrombosis; vaccines; botulinum neurotoxins; and, more recently, biosimilar preparations, comprising the majority of approved biologics. Written with clinicians, other health care professionals, and researchers in mind, Safety of Biologics Therapy examines, in a single volume, the full range of issues surrounding the safety of approved biologic therapies. A good understanding of the risks and safety issues of modern biologics therapy is increasingly being demanded of all those connected with their development, handling, prescribing, administration and subsequent patient management. In addition to being of great value to clinicians in all branches of medicine, and to nurses, pharmacists and researchers, this book will prove invaluable for students taking undergraduate and graduate courses in the above disciplines and in the biomedical sciences.

Download or read book Monoclonal Antibodies in Cancer written by Stewart Sell and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Structure and Function of Antibodies written by Roy Jefferis and published by MDPI. This book was released on 2021-02-05 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a detailed description of all kinds of therapeutic antibodies including IgGs, IgAs, IgEs, and IgMs, bispecific antibodies, chimeric antigen receptor antibodies, and antibody fragments. Details about how each of these antibodies interact with their ligands, the immune system, and their targets are provided. Additionally, this book delves into the details of antibody, Fc, and variable chain structures, and how subtle changes in structure, charge, flexibility, post-translational modification, and the ability to bind to natural antibody ligands can result in a significant impact on antibody activity and functionality. Finally, the book explains the critical quality attributes of modern therapeutic antibodies and how to ensure that antibodies entering development have the best possible chance of success.

Download or read book Introduction to Antibody Engineering written by Florian Rüker and published by Springer Nature. This book was released on 2021-01-04 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: This highly readable textbook serves as a concise and engaging primer to the emerging field of antibody engineering and its various applications. It introduces readers to the basic science and molecular structure of antibodies, and explores how to characterize and engineer them. Readers will find an overview of the latest methods in antibody identification, improvement and biochemical engineering. Furthermore, alternative antibody formats and bispecific antibodies are discussed. The book’s content is based on lectures for the specializations “Protein Engineering” and “Medical Biotechnology” within the Master’s curriculum in “Biotechnology.” The lectures have been held at the University of Natural Resources and Life Sciences, Vienna, in cooperation with the Medical University of Vienna, since 2012 and are continuously adapted to reflect the latest developments in the field. The book addresses Master’s and PhD students in biotechnology, molecular biology and immunology, and all those who are interested in antibody engineering.

Download or read book Monoclonal Antibodies and Functional Cell Lines written by Roger H. Kennett and published by Springer Science & Business Media. This book was released on 2013-03-08 with total page 427 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume serves as a follow-up to our previous book, MonoclonalAntibodies Hybridomas: A New Dimension in Biological Analyses. We continue the theme of monoclonal antibodies and their applications, attempting to cover some of the areas not covered in the previous volume. We again include an appendix de scribing methods useful to those who ar-e beginning to apply these techniques in their own laboratories. This volume will be followed by another concentrating on the combination of monoclonal antibody techniques with molecular genetic techniques to study structure/function relationships at the level of both the gene and gene product. Roger H. Kennett Kathleen B. Bechtol Philadelphia, Pennsylvania Thomas J. McKearn Princeton, New Jersey IX Acknowledgments Roger Kennett acknowledges the patience and support of his wife, Carol, and his family, friends, and colleagues during the work on this volume, and again thanks, above all, the Lord, Jesus Christ. Kathleen Bechtol wishes to thank colleagues and friends for their support and understanding during the months of preparation of this volume. Tom McKearn acknowledges and thanks his wife, Pat, and his family for their support and encouragement. Xl Contents PART I INTRODUCTION 1 Introduction: Reflections on Nine Years of Monoclonal Antibodies from Hybridomas 3 ROGER H. KENNETT, KATHLEEN B. BECHTOL, AND THOMAS J. McKEARN 1. Biotechnology'S "Coming of Age". . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 II. Monoclonal Antibodies-An Overview of Applications. . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 III. Commercialization of Monoclonal Antibody Technology.. . . .. ... . .... .... .. . ... . . 10 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 . . . . . . . . . . . . . . . . . . . . .

Download or read book Cell Line Development written by Mohamed Al-Rubeai and published by Springer Science & Business Media. This book was released on 2009-08-11 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mammalian cell lines command an effective monopoly for the production of therapeutic proteins that require post-translational modifications. This unique advantage outweighs the costs associated with mammalian cell culture, which are far grater in terms of development time and manufacturing when compared to microbial culture. The development of cell lines has undergone several advances over the years, essentially to meet the requirement to cut the time and costs associated with using such a complex hosts as production platforms. This book provides a comprehensive guide to the methodology involved in the development of cell lines and the cell engineering approach that can be employed to enhance productivity, improve cell function, glycosylation and secretion and control apoptosis. It presents an overall picture of the current topics central to expression engineering including such topics as epigenetics and the use of technologies to overcome positional dependent inactivation, the use of promoter and enhancer sequences for expression of various transgenes, site directed engineering of defined chromosomal sites, and examination of the role of eukaryotic nucleus as the controller of expression of genes that are introduced for production of a desired product. It includes a review of selection methods for high producers and an application developed by a major biopharmaceutical industry to expedite the cell line development process. The potential of cell engineering approch to enhance cell lines through the manipulation of single genes that play important roles in key metabolic and regulatory pathways is also explored throughout.

Download or read book Antibody Drug Discovery written by Clive R. Wood and published by World Scientific. This book was released on 2012 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: Antibody-based therapeutics are a central driver of the success of biopharmaceuticals. The discovery technology of this field is isolated to a limited number of centers of excellence in industry and academia. The objective of this volume is to provide a series of guides to those evaluating and preparing to enter particular areas within the field. Each chapter is written with a historical perspective that sets into context the significance of the key developments, and with the provision of “points to consider” for the reader as a value-added feature of the volume. All contributors are experts in their fields and have played pivotal roles in the creation of the technology.

Download or read book Monoclonal Antibodies written by Vincent Ossipow and published by Humana. This book was released on 2016-08-23 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Monoclonal Antibodies: Methods and Protocols, Second Edition expands upon the previous edition with current, detailed modern approaches to isolate and characterize monoclonal antibodies against carefully selected epitopes. This edition includes new chapters covering the key steps to generate high quality monoclonals via different methods, from antigen generation to epitope mapping and quality control of the purified IgG. Chapters are divided into four parts corresponding to four distinct objectives. Part I covers monoclonal antibody generation, Part II deals with monoclonal antibody expression and purification, Part III presents methods for monoclonal antibody characterization and modification, and Part IV describes selected applications of monoclonal antibodies. Written in the highly 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 laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and practical, Monoclonal Antibodies: Methods and Protocols, Second Edition provides crucial initial steps of monoclonal antibody generation and characterization with state-of-the art protocols.

Download or read book Therapeutic Antibodies written by Yuti Chernajovsky and published by Springer. This book was released on 2007-11-22 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: This essential work, edited by two researchers at London’s famous Queen Mary’s medical school targets one of the most important areas in medical development today. These days, antibody therapeutics are the treatment of choice for several autoimmune and oncological conditions. They are, indeed, becoming the molecules of choice for further combination therapies and cell engineering. In this timely work, a slew of expert in the field of drug development summarize all the current developments and clinical successes.