Trends In Monoclonal Antibody Research

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Current Trends in Monoclonal Antibody Development and Manufacturing

Author : Steven J. Shire
Publisher : Springer Science & Business Media
ISBN 13 : 038776643X
Total Pages : 348 pages
Book Rating : 4.3/5 (877 download)

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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.

Trends in Monoclonal Antibody Research

Author : Marie A. Simmons
Publisher : Nova Publishers
ISBN 13 : 9781594545504
Total Pages : 160 pages
Book Rating : 4.5/5 (455 download)

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Book Synopsis Trends in Monoclonal Antibody Research by : Marie A. Simmons

Download or read book Trends in Monoclonal Antibody Research written by Marie A. Simmons and published by Nova Publishers. This book was released on 2005 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new and important international source of information brings together leading-edge research dedicated to monoclonal antibodies. Monoclonal antibodies (MABs) are: antibodies of exceptional purity and specificity; components of the immune system; able to recognise and bind to a specific antigen. Monoclonal antibodies are currently utilised in many diagnostic procedures, including: measuring protein and drug levels in serum; typing tissue and blood; identifying infectious agents; identifying clusters of differentiation for the classification and follow-up therapy of leukaemias and lymphomas; identifying tumour antigens and auto-antibodies; identifying the specific cells involved in the immune response; identifying and quantifying hormones. For example, monoclonal antibodies (MABs or MOABs) work on cancer cells in the same way natural antibodies work, by identifying and binding to the target cells. They then alert other cells in the immune system to the presence of the cancer cells. MABs are specific for a particular antigen-one designed for a B-cell lymphoma will not work on cells for ovarian cancer cells for example.

Monoclonal Antibody Production

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309173051
Total Pages : 74 pages
Book Rating : 4.3/5 (91 download)

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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.

Monoclonal Antibodies

Author : James W. Goding
Publisher :
ISBN 13 :
Total Pages : 344 pages
Book Rating : 4.3/5 (91 download)

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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.

Handbook of Therapeutic Antibodies

Author : Stefan Dübel
Publisher : John Wiley & Sons
ISBN 13 : 3527329374
Total Pages : 2538 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Handbook of Therapeutic Antibodies by : Stefan Dübel

Download or read book Handbook of Therapeutic Antibodies written by Stefan Dübel and published by John Wiley & Sons. This book was released on 2014-12-03 with total page 2538 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Process Scale Purification of Antibodies

Author : Uwe Gottschalk
Publisher : John Wiley & Sons
ISBN 13 : 1119126932
Total Pages : 849 pages
Book Rating : 4.1/5 (191 download)

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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

Therapeutic Antibodies

Author : Yuti Chernajovsky
Publisher : Springer
ISBN 13 : 9783540732587
Total Pages : 380 pages
Book Rating : 4.7/5 (325 download)

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Book Synopsis Therapeutic Antibodies by : Yuti Chernajovsky

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.

Therapeutic Antibody Engineering

Author : William R Strohl
Publisher : Elsevier
ISBN 13 : 1908818093
Total Pages : 697 pages
Book Rating : 4.9/5 (88 download)

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Book Synopsis Therapeutic Antibody Engineering by : William R Strohl

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

State-Of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization

Download State-Of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization PDF Online Free

Author : John E. Schiel
Publisher : ACS Symposium
ISBN 13 : 9780841230293
Total Pages : 0 pages
Book Rating : 4.2/5 (32 download)

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Book Synopsis State-Of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization by : John E. Schiel

Download or read book State-Of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization written by John E. Schiel and published by ACS Symposium. This book was released on 2016-06-24 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Distributed in print by Oxford University Press."

Biosimilars of Monoclonal Antibodies

Author : Cheng Liu
Publisher : John Wiley & Sons
ISBN 13 : 1118940628
Total Pages : 723 pages
Book Rating : 4.1/5 (189 download)

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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

Safety of Biologics Therapy

Author : Brian A. Baldo
Publisher : Springer
ISBN 13 : 3319304720
Total Pages : 623 pages
Book Rating : 4.3/5 (193 download)

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Book Synopsis Safety of Biologics Therapy by : Brian A. Baldo

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.

Antibody-Drug Conjugates

Author : Kenneth J. Olivier, Jr.
Publisher : John Wiley & Sons
ISBN 13 : 1119060842
Total Pages : 567 pages
Book Rating : 4.1/5 (19 download)

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Book Synopsis Antibody-Drug Conjugates by : Kenneth J. Olivier, Jr.

Download or read book Antibody-Drug Conjugates written by Kenneth J. Olivier, Jr. and published by John Wiley & Sons. This book was released on 2016-11-14 with total page 567 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing practical and proven solutions for antibody-drug conjugate (ADC) drug discovery success in oncology, this book helps readers improve the drug safety and therapeutic efficacy of ADCs to kill targeted tumor cells. • Discusses the basics, drug delivery strategies, pharmacology and toxicology, and regulatory approval strategies • Covers the conduct and design of oncology clinical trials and the use of ADCs for tumor imaging • Includes case studies of ADCs in oncology drug development • Features contributions from highly-regarded experts on the frontlines of ADC research and development

Antibody Drug Discovery

Author : Clive R. Wood
Publisher : World Scientific
ISBN 13 : 1848166281
Total Pages : 490 pages
Book Rating : 4.8/5 (481 download)

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Book Synopsis Antibody Drug Discovery by : Clive R. Wood

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.

Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing

Author : Ganapathy Subramanian
Publisher : John Wiley & Sons
ISBN 13 : 3527347690
Total Pages : 404 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing by : Ganapathy Subramanian

Download or read book Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2021-12-20 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Antibodies for Infectious Diseases

Author : James E. Crowe, Jr.
Publisher : John Wiley & Sons
ISBN 13 : 1555817416
Total Pages : 457 pages
Book Rating : 4.5/5 (558 download)

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Book Synopsis Antibodies for Infectious Diseases by : James E. Crowe, Jr.

Download or read book Antibodies for Infectious Diseases written by James E. Crowe, Jr. and published by John Wiley & Sons. This book was released on 2020-07-24 with total page 457 pages. Available in PDF, EPUB and Kindle. Book excerpt: State-of-the-art reviews covering major aspects of antibodies and intervention against infectious diseases The connection between antibodies and infectious diseases has spawned entire related fields of study. Antibodies for Infectious Diseases presents perspectives from leading research scientists and summarizes the amazing progress in this area into a single definitive source. Providing a broad survey of the most important aspects of the field of antibodies for infectious diseases, this book presents general features pertaining to structure, function, isotype, and the role of complement in antibody function examines the role of antibodies in antimicrobial immunity with specific targets details new methods for expression of monoclonal antibodies, in plants or by transfer of antibody genes for in vivo expression in treated subjects Antibodies for Infectious Diseases is a comprehensive reference for researchers, pharmaceutical developers, and health care professionals on the status of the development of antibody-based therapies for treating infectious diseases. It is also useful as supplemental reading for upper level life sciences students.

Biopharmaceutical Processing

Author : Gunter Jagschies
Publisher : Elsevier
ISBN 13 : 0128125527
Total Pages : 1310 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Biopharmaceutical Processing by : Gunter Jagschies

Download or read book Biopharmaceutical Processing written by Gunter Jagschies and published by Elsevier. This book was released on 2018-01-18 with total page 1310 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. - Offers a comprehensive, go-to reference for daily work decisions - Covers both upstream and downstream processes - Includes case studies that emphasize financial outcomes - Presents summaries, decision grids, graphs and overviews for quick reference

Fermentation Processes

Author : Angela Jozala
Publisher : BoD – Books on Demand
ISBN 13 : 9535129279
Total Pages : 314 pages
Book Rating : 4.5/5 (351 download)

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Book Synopsis Fermentation Processes by : Angela Jozala

Download or read book Fermentation Processes written by Angela Jozala and published by BoD – Books on Demand. This book was released on 2017-02-08 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fermentation is a theme widely useful for food, feed and biofuel production. Indeed each of these areas, food industry, animal nutrition and energy production, has considerable presence in the global market. Fermentation process also has relevant applications on medical and pharmaceutical areas, such as antibiotics production. The present book, Fermentation Processes, reflects that wide value of fermentation in related areas. It holds a total of 14 chapters over diverse areas of fermentation research.