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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.
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.
Soon after the first description of monoclonal antibodies in 1976, there was enormous interest in the clinical application of antibodies, especially in the context of cancer. Antibodies appeared to offer the “magic bullet” that would allow the specific destruction of neoplastic cells. H- ever, many years’ effort resulted in very few cases of successful immu- therapy with antibodies. As a result there was a major backlash against antibody therapy, and the field lost a considerable amount of popularity. Fashion, in science as well as in other things, tends to be cyclical. Antibody-based therapy is once again attracting scientists and clinicians. There are several reasons for the renewed optimism; certainly the expe- ence of the last two decades has provided a wealth of information about problems associated with antibody therapy, and possible solutions to these problems. Recombinant antibody engineering has rejuvenated the field, allowing both the modification of antibodies to improve their in vivo pr- erties and the isolation of novel antibody molecules by such techniques as phage display. The results of recent clinical trials have demonstrated unequivocally the benefit of antibody therapy in a number of settings, and, finally, more careful consideration has been taken of the types of disease best treated using this approach.
Dieses Nachschlagewerk zu therapeutischen Antikörpern sucht auch in der komplett überarbeiteten 2. Auflage seinesgleichen und bietet 30 % neue Inhalte zu Entwicklung, Herstellung und therapeutischen Anwendungen dieser Biomoleküle.
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.
The applicability of immunotechniques to a wide variety of research problems in many areas of biology and chemistry has expanded dramatically over the last two decades ever since the introduction of monoclonal antibodies and sophisticated immunosorbent techniques. Exquisitely specific antibody molecules provide means of separation, quantitative and qualitative analysis, and localization useful to anyone doing biological or biochemical research. This practical guide to immunotechniques is especially designed to be easily understood by people with little practical experience using antibodies. It clearly presents detailed, easy-to-follow, step-by-step methods for the widely used techniques that exploit the unique properties of antibodies and will help researchers use antibodies to their maximum advantage. Key Features * Detailed, easy-to-follow, step-by-step protocols * Convenient, easy-to-use format * Extensive practical information * Essential background information * Helpful hints
The book deals with therapeutic monoclonal antibodies (mAbs) broadly, and relevant topics such as challenges and opportunities, next-generation antibody products, Antibody-Drug-Conjugates (ADC), bispecifics, glycosylation, and T-cell engagers are covered. Each topic has been written by leading groups around the world and the book should be of interest to researchers from both academia and industry.
Written by a leading researcher in immunology, ImmunoPharmaceuticals specifically focuses on immunologically active drugs recently tested for clinical activity or recently approved for medical use. Each chapter focuses on a single drug or class of drugs and discusses data from basic and preclinical research concerning mechanisms of action. Preclinical models are compared with clinical findings to allow the reader to evaluate the predictive value of those models. Featured drugs are being studied for therapy of cancer, arthritic disease, autoimmune disease, immunodeficiency disease, transplantation, and determination of sepsis. Overviews of the retinoids in cancer therapy and preclinical studies on flavonoids are featured.
This book examines a collection of state-of-the-art methods that employ monoclonal antibodies in a clinical setting. The chapters offer in-depth description for generating mouse and recombinant humanized antibodies, and a comprehensive review of how antibodies are being used in bead-based methods for measuring proteins. This field will continue to expand and provide new and innovative techniques in the laboratory and as a basis that complements targeted therapy.