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Monoclonal Antibodies
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Book Synopsis Monoclonal Antibodies by : James W. Goding
Download or read book Monoclonal Antibodies written by James W. Goding and published by . This book was released on 1986 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book represents the distillation and critical evaluation of many hundreds of publications relating to the production and use of antibodies. Therefore it is restricted to the "core" techniques of production and handling of antibodies, and their use in studies of antigen analysis, purification and localization.
Book Synopsis Monoclonal Antibody Production by : National Research Council
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 Drug-Induced Liver Injury written by and published by Academic Press. This book was released on 2019-07-13 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug-Induced Liver Injury, Volume 85, the newest volume in the Advances in Pharmacology series, presents a variety of chapters from the best authors in the field. Chapters in this new release include Cell death mechanisms in DILI, Mitochondria in DILI, Primary hepatocytes and their cultures for the testing of drug-induced liver injury, MetaHeps an alternate approach to identify IDILI, Autophagy and DILI, Biomarkers and DILI, Regeneration and DILI, Drug-induced liver injury in obesity and nonalcoholic fatty liver disease, Mechanisms of Idiosyncratic Drug-Induced Liver Injury, the Evaluation and Treatment of Acetaminophen Toxicity, and much more. - Includes the authority and expertise of leading contributors in pharmacology - Presents the latest release in the Advances in Pharmacology series
Book Synopsis Monoclonal Antibodies by : Steven Shire
Download or read book Monoclonal Antibodies written by Steven Shire and published by Woodhead Publishing. This book was released on 2015-04-24 with total page 227 pages. Available in PDF, EPUB and Kindle. Book excerpt: Monoclonal antibodies (MAbs) are currently the major class of protein bio therapeutic being developed by biotechnology and pharmaceutical companies. Monoclonal Antibodies discusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology into a therapeutic agent.This book covers downstream processing which includes design of processes to manufacture the formulation, formulation design, fill and finish into closure systems and routes of administration. The characterization of the final drug product is covered where the use of biophysical methods combined with genetic engineering is used to understand the solution properties of the formulation. The latter has become very important since many indications such as arthritis and asthma require the development of formulations for subcutaneous delivery (SC). The development of formulations for IV delivery is also important and comes with a different set of challenges. The challenges and strategies that can overcome these limitations are discussed in this book, starting with an introduction to these issues, followed by chapters detailing strategies to deal with them. Subsequent chapters explore the processing and storage of mAbs, development of delivery device technologies and conclude with a chapter on the future of mAbs in therapeutic remedies. - Discusses the challenges to develop MAbs for intravenous (IV) and subcutaneous delivery (SC) - Presents strategies to meet the challenges in development of MAbs for SC and IV administration - Discusses the use of biophysical analytical tools coupled with MAb engineering to understand what governs MAb properties at high concentration
Book Synopsis Monoclonal Antibodies by : Vincent Ossipow
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.
Book Synopsis Monoclonal Antibodies by : Harleen Kaur
Download or read book Monoclonal Antibodies written by Harleen Kaur and published by Elsevier. This book was released on 2021-08-03 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: Monoclonal antibodies (mAbs) are naturally occurring complex biomolecules. New engineering methods have turned mAbs into a leading therapeutic modality for addressing immunotherapeutic challenges and led to the rise of mAbs as the dominant class of protein therapeutics. mAbs have already demonstrated a great potential in developing safe and reliable treatments for complex diseases and creating more affordable healthcare alternatives. Developing mAbs into well-characterized antibody therapeutics that meet regulatory expectations, however, is extremely challenging. Obstacles to overcome include the determination and development of physiochemical characteristics such as aggregation, fragmentation, charge variants, identity, carbohydrate structure, and higher-order structure (HOS). This book dives deep into mAbs structure and the array of physiochemical testing and characterization methods that need to be developed and validated to establish a mAb as a therapeutic molecule. The main focus of this book is on physiochemical aspects, including the importance of establishing quality attributes such as glycosylation, primary sequence, purity, and HOS and elucidating the structure of new antibody formats by mass spectrometry. Each of the aforementioned quality attributes has been discussed in detail; this will help scientists in researching and developing biopharmaceuticals and biosimilars to find practical solutions to physicochemical testing and characterization. - Describes the spectrum of analytical tests and characterization methods necessary for developing and releasing mAb batches - Details antibody heterogeneity in terms of size, charge, and carbohydrate content - Gives special focus to the structural analysis of mAbs, including mass spectrometry analysis - Presents the basic structure of mAbs with clarity and rigor - Addresses regulatory guidelines - including ICH Q6B - in relation to quality attributes - Lays out characterization and development case studies including biosimilars and new antibody formats
Book Synopsis The Pharmacology of Monoclonal Antibodies by : Martin Rosenberg
Download or read book The Pharmacology of Monoclonal Antibodies written by Martin Rosenberg and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 414 pages. Available in PDF, EPUB and Kindle. Book excerpt: A sample of the most exciting developments in the cloning, manipulation, expression and application of genetically-engineered monoclonal antibodies. This rapidly-evolving field has witnessed the PCR combinatorial cloning of vast immunological diversity, in vitro mutagenesis of MAbs, MAbs created by transgenic animals, novel expression systems in plants, animals and lower systems, as well as a rich variety of genetically modified MAbs as potential therapeutic agents. Leading scientists from academia and industry present their own findings as well as short reviews of these research areas.
Book Synopsis Therapeutic Monoclonal Antibodies by : Zhiqiang An
Download or read book Therapeutic Monoclonal Antibodies written by Zhiqiang An and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 932 pages. Available in PDF, EPUB and Kindle. Book excerpt: 70-chapter authoritative reference that covers therapeutic monoclonal antibody discovery, development, and clinical applications while incorporating principles, experimental data, and methodologies. First book to address the discovery and development of antibody therapeutics in their entirety. Most chapters contain experimental data to illustrate the principles described in them. Authors provide detailed methodologies that readers can take away with them and use in their own laboratories.
Book Synopsis Monoclonal Antibodies in Headache by : Antoinette Maassen van den Brink
Download or read book Monoclonal Antibodies in Headache written by Antoinette Maassen van den Brink and published by Springer Nature. This book was released on 2021-04-28 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt: Intended to promote a more appropriate and modern therapeutic approach to migraine management, this book is the first to deal with monoclonal antibodies in this context. Authored by the most respected migraine experts from around the globe and drawing on the lessons learned in both clinical trials and clinical practice, it reviews the current state of knowledge on this important therapeutic innovation, which has produced impressive data in randomized controlled trials, and the efficacy and safety of which have been confirmed in day-to-day real-world use. Given its scope, the book will appeal to a broad range of specialists, including pharmacologists, clinical pharmacologists, neurologists and internists, but also to residents and medical students.
Book Synopsis The Lock and Key of Medicine by : Lara V. Marks
Download or read book The Lock and Key of Medicine written by Lara V. Marks and published by Yale University Press. This book was released on 2015-06-28 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the first to tell the extraordinary yet unheralded history of monoclonal antibodies. Often referred to as Mabs, they are unfamiliar to most nonscientists, yet these microscopic protein molecules are everywhere, quietly shaping our lives and healthcare. Discovered in the mid-1970s in the laboratory where Watson and Crick had earlier unveiled the structure of DNA, Mabs have radically changed understandings of the pathways of disease. They have enabled faster, cheaper, and more accurate clinical diagnostic testing on a vast scale. And they have played a fundamental role in pharmaceutical innovation, leading to such developments as recombinant interferon and insulin, and personalized drug therapies such as Herceptin. Today Mabs constitute six of the world’s top ten blockbuster drugs and make up a third of new introduced treatments. Lara V. Marks recounts the risks and opposition that a daring handful of individuals faced while discovering and developing Mabs, and she addresses the related scientific, medical, technological, business, and social challenges that arose. She offers a saga of entrepreneurs whose persistence and creativity ultimately changed the healthcare landscape and brought untold relief to millions of patients. Even so, as Marks shows, controversies over Mabs remain, and she examines current debates over the costs and effectiveness of these innovative drugs.
Book Synopsis Human Monoclonal Antibodies by : Michael Steinitz
Download or read book Human Monoclonal Antibodies written by Michael Steinitz and published by Humana Press. This book was released on 2013-09-14 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Monoclonal Antibodies by : Maher Albitar
Download or read book Monoclonal Antibodies written by Maher Albitar and published by Springer Science & Business Media. This book was released on 2008-02-02 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Current Trends in Monoclonal Antibody Development and Manufacturing by : Steven J. Shire
Download or read book Current Trends in Monoclonal Antibody Development and Manufacturing written by Steven J. Shire and published by Springer Science & Business Media. This book was released on 2009-11-11 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Antibodies and Their Role in Therapeutics by : Roohi Bansal
Download or read book Antibodies and Their Role in Therapeutics written by Roohi Bansal and published by Roohi Bansal. This book was released on 2021-12-04 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: Beginning with the structure, types, functions, and gene organization of antibodies, the book aims to shine a detailed light on the monoclonal antibodies (often referred to as mAbs) that have revolutionized the fields of therapeutics and diagnostics. The book describes the different ways of generating chimeric, humanized, and fully human monoclonal antibodies, emphasizing phage display, hybridoma, and rDNA technology. In addition, the book focuses on the various recombinant antibody formats in detail: Drug conjugates: Antibody-drug conjugates (ADCs), Immunotoxins (Recombinant, Humanized and Fully Human) and Antibody-antibiotic conjugate (AAC) Bispecific antibodies: scFv based (BiTE, DARTs and TandAbs) and Full-length IgG based Abzymes and Antibody-directed enzyme prodrug therapy (ADEPT) Fc-fusion proteins Single-domain antibodies (VHH and IgNAR sdAb) The book discusses the various therapeutic applications of monoclonal antibodies, along with the immunogenicity issues. The book also covers the modes of administration and side effects of monoclonal antibodies, along with the challenges and issues faced while developing a monoclonal antibody into a therapeutic agent. Modifications introduced by the researchers to decrease the immunogenicity issues and increase the efficacy of therapeutic mAbs are also described. The book is an invaluable resource for researchers and students in biology and medicine, biotechnology, immunology, genetics, molecular biology, and anyone interested in antibody engineering.
Book Synopsis Biosimilars of Monoclonal Antibodies by : Cheng Liu
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
Book Synopsis Monoclonal Antibodies by : Christian Klein
Download or read book Monoclonal Antibodies written by Christian Klein and published by . This book was released on 2018 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Process Scale Purification of Antibodies by : Uwe Gottschalk
Download or read book Process Scale Purification of Antibodies written by Uwe Gottschalk and published by John Wiley & Sons. This book was released on 2017-03-07 with total page 849 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
