Monoclonal Antibodies Book

Monoclonal Antibodies


  • Author : Harleen Kaur
  • Publisher : Elsevier
  • Release Date : 2021-08-03
  • Genre: Medical
  • Pages : 258
  • ISBN 10 : 9780128223192

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Monoclonal Antibodies 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 biosimila

Monoclonal Antibodies Book

Monoclonal Antibodies


  • Author : Steven Shire
  • Publisher : Woodhead Publishing
  • Release Date : 2015-04-24
  • Genre: Medical
  • Pages : 224
  • ISBN 10 : 9780081002971

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Monoclonal Antibodies 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

Monoclonal Antibody Production Book

Monoclonal Antibody Production


  • Author : National Research Council
  • Publisher : National Academies Press
  • Release Date : 1999-06-06
  • Genre: Medical
  • Pages : 74
  • ISBN 10 : 9780309064477

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Monoclonal Antibody Production 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.

Drug Induced Liver Injury Book
Score: 5
From 5 Ratings

Drug Induced Liver Injury


  • Author : Anonim
  • Publisher : Academic Press
  • Release Date : 2019-07-13
  • Genre: Medical
  • Pages : 288
  • ISBN 10 : 9780128173176

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Drug Induced Liver Injury 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

Monoclonal Antibodies Book

Monoclonal Antibodies


  • Author : James W. Goding
  • Publisher : Unknown
  • Release Date : 1986
  • Genre: Antibodies, Monoclonal
  • Pages : 315
  • ISBN 10 : UOM:39015012462928

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Monoclonal Antibodies 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.

Monoclonal Antibodies Book

Monoclonal Antibodies


  • Author : Vincent Ossipow
  • Publisher : Humana Press
  • Release Date : 2016-08-23
  • Genre: Medical
  • Pages : 575
  • ISBN 10 : 1493963228

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Monoclonal Antibodies 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.

Monoclonal Antibodies in Headache Book

Monoclonal Antibodies in Headache


  • Author : Antoinette Maassen van den Brink
  • Publisher : Springer Nature
  • Release Date : 2021-04-28
  • Genre: Medical
  • Pages : 172
  • ISBN 10 : 9783030690328

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Monoclonal Antibodies in Headache 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.

Biosimilars of Monoclonal Antibodies Book

Biosimilars of Monoclonal Antibodies


  • Author : Cheng Liu
  • Publisher : John Wiley & Sons
  • Release Date : 2016-12-19
  • Genre: Medical
  • Pages : 720
  • ISBN 10 : 9781118662311

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Biosimilars of Monoclonal Antibodies 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

Human Monoclonal Antibodies Book

Human Monoclonal Antibodies


  • Author : Michael Steinitz
  • Publisher : Humana Press
  • Release Date : 2013-09-30
  • Genre: Medical
  • Pages : 364
  • ISBN 10 : 1627035850

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Human Monoclonal Antibodies 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.

Process Scale Purification of Antibodies Book

Process Scale Purification of Antibodies


  • Author : Uwe Gottschalk
  • Publisher : John Wiley & Sons
  • Release Date : 2017-04-03
  • Genre: Medical
  • Pages : 752
  • ISBN 10 : 9781119126911

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Process Scale Purification of Antibodies 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

Production and Characterization of Monoclonal Antibodies Directed Against Cell Surface Antigens of Canine Keratinocytes and Induction of Antibody mediated Lesions in Stratified Squamous Epithelium Using Monoclonal Antibodies Book

Production and Characterization of Monoclonal Antibodies Directed Against Cell Surface Antigens of Canine Keratinocytes and Induction of Antibody mediated Lesions in Stratified Squamous Epithelium Using Monoclonal Antibodies


  • Author : Maja M. Suter
  • Publisher : Unknown
  • Release Date : 1988
  • Genre: Cell surface antigens
  • Pages : 320
  • ISBN 10 : CORNELL:31924050420367

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Production and Characterization of Monoclonal Antibodies Directed Against Cell Surface Antigens of Canine Keratinocytes and Induction of Antibody mediated Lesions in Stratified Squamous Epithelium Using Monoclonal Antibodies Excerpt :