Commercial Production of Monoclonal Antibodies PDF Download
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Author: Sally S. Seaver
Publisher: Marcel Dekker
ISBN:
Category : Medical
Languages : en
Pages : 360
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Book Description
Author: Sally S. Seaver
Publisher: Marcel Dekker
ISBN:
Category : Medical
Languages : en
Pages : 360
Get Book Here
Book Description
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: J. Eryl Liddell
Publisher: John Wiley & Sons
ISBN: 9780471929055
Category : Medical
Languages : en
Pages : 212
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Book Description
Includes all of the information required to produce monoclonal antibodies in the laboratory and to prepare them for use in a multitude of given applications. Production procedures are treated in chronological order, beginning with basic tissue culture techniques, immunization strategies and screening test design, followed by production of hybridoma cell lines and basic antibody characterization, purification and labeling. Each chapter contains explanatory text on each step with comparative analysis of methods where appropriate. All necessary experimental protocols are presented in a self-contained format that is easy to follow in the laboratory. Alternative protocols are provided where relevant; for others not included in full, source references are presented. Surveys the current status of human hybridoma production and antibody engineering using molecular biology techniques.
Author: Angela Jozala
Publisher: BoD – Books on Demand
ISBN: 9535129279
Category : Technology & Engineering
Languages : en
Pages : 314
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Book Description
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.
Author: David J. King
Publisher: CRC Press
ISBN: 9780748404223
Category : Medical
Languages : en
Pages : 262
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Book Description
A valuable resource for researchers and workers in the fields of both pharmaceuticals and biotechnology as well as undergraduates in biochemistry, applied biology, biomedical sciences and pharmacy, this book compares established techniques of antibody production with the new. Antibody structure and the implications of antibody engineering are fully discussed, and a case study approach illustrates how antibodies are finding increasing use in the diagnosis and treatment of disease. The volume ends with commercial expression, purification and large-scale manufacture of antibodies and their future potential, particularly as therapeutic agents.
Author: Lara V. Marks
Publisher: Yale University Press
ISBN: 0300213522
Category : Medical
Languages : en
Pages : 345
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Book Description
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.
Author: Brian A. Baldo
Publisher: Springer
ISBN: 3319304720
Category : Medical
Languages : en
Pages : 623
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Book Description
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.
Author: Arnold L. Demain
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 854
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Book Description
The editors have enlisted a broad range of experts, including microbial ecologists, physiologists, geneticists, biochemists, molecular biologists, and biochemical engineers, who offer practical experience not found in texts and journals. This comprehensive perspective makes MIMB a valuable "how to" resource, the structure of which resembles the sequence of operation involved in the development of a commercial biological process and product.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309487811
Category : Medical
Languages : en
Pages : 69
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Book Description
On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
