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Author: Steven J. Shire
Publisher: Springer Science & Business Media
ISBN: 038776643X
Category : Medical
Languages : en
Pages : 348
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Book Description
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.
Author: Steven J. Shire
Publisher: Springer Science & Business Media
ISBN: 038776643X
Category : Medical
Languages : en
Pages : 348
Get Book Here
Book Description
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.
Author: William R Strohl
Publisher: Elsevier
ISBN: 1908818093
Category : Medical
Languages : en
Pages : 697
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Book Description
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
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309173051
Category : Medical
Languages : en
Pages : 74
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Book Description
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.
Author: Uwe Gottschalk
Publisher: John Wiley & Sons
ISBN: 1119126932
Category : Medical
Languages : en
Pages : 849
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Book Description
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
Author: Allan Matte
Publisher: Elsevier
ISBN: 0081030193
Category : Medical
Languages : en
Pages : 222
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Book Description
Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics provides the interested and informed reader with an overview of current approaches, strategies and considerations relating to the purification, analytics and characterization of therapeutic antibodies and related molecules. While there are obviously other books published in and around this subject area, they seem to be either older (c.a. year 2000 publication date) or are more limited in scope. The book will include an extensive bibliography of the published literature in the respective areas covered. It is not, however, intended to be a how-to methods book.
Author: Bob Kiss
Publisher: Springer
ISBN: 3319971107
Category : Science
Languages : en
Pages : 473
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Book Description
This book review series presents current trends in modern biotechnology. The aim is to cover all aspects of this interdisciplinary technology where knowledge, methods and expertise are required from chemistry, biochemistry, microbiology, genetics, chemical engineering and computer science. Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. The series also discusses new discoveries and applications. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification. In general, special volumes are edited by well-known guest editors. The series editor and publisher will however always be pleased to receive suggestions and supplementary information. Manuscripts are accepted in English.
Author: Cheng Liu
Publisher: John Wiley & Sons
ISBN: 1118940628
Category : Medical
Languages : en
Pages : 723
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Book Description
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
Author: Clive R. Wood
Publisher: World Scientific
ISBN: 1848166281
Category : Medical
Languages : en
Pages : 490
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Book Description
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.
Author: Ganapathy Subramanian
Publisher: John Wiley & Sons
ISBN: 3527347690
Category : Technology & Engineering
Languages : en
Pages : 404
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Book Description
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.
Author: Kenneth J. Olivier, Jr.
Publisher: John Wiley & Sons
ISBN: 111906080X
Category : Medical
Languages : en
Pages : 474
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Book Description
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
