Download or read book Antibody Expression and Production written by Mohamed Al-Rubeai and published by Springer Science & Business Media. This book was released on 2011-05-16 with total page 349 pages. Available in PDF, EPUB and Kindle. Book excerpt: Engineered antibodies currently represent over 30% of biopharmaceuticals in clinical trials and their total worldwide sales continue to increase significantly. The importance of antibody applications is reflected in their increasing clinical and industrial applications as well as in the progression of established and emerging production strategies. This volume provides detailed coverage of the generation, optimization, characterization, production and applications of antibody. It provides the necessary theoretical background and description of methods for the expression of antibody in microbial and animal cell cultures and in transgenic animals and plants. There is a strong focus on those issues related to the production of intrabodies, bispecific antibody and antibody fragments and also to novel applications in cancer immunotherapy.
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 Recombinant Protein Expression Eukaryotic hosts written by and published by Academic Press. This book was released on 2021-11-04 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recombinant Protein Expression, Part B, Volume 660 in the Methods in Enzymology series, highlights new advances in the field with this new volume presenting interesting chapters on Multiplexed analysis protein: Protein interactions of polypeptides translated in Leishmania cell-free system, MultiBac system and its applications, performance and recent, Production of antibodies in Shuffle, Designing hybrid-promoter architectures by engineering cis-acting DNA sites to enhance transcription in yeast, Designing hybrid-promoter architectures by engineering cis-acting DNA sites to deregulate transcription in yeast, Antibody or protein-based vaccine production in plants, Cell-free protein synthesis, Plant-based expression of biologic drugs, and much more. Additional sections cover the Use of native mass spectrometry to guide detergent-based rescue of non-native oligomerization by recombinant proteins, Advancing overexpression and purification of recombinant proteins by pilot optimization through tandem affinity-buffer exchange chromatography online with native mass spectrometry, Method for High-Efficiency Fed-batch cultures of recombinant Escherichia coli, Method to transfer Chinese hamster ovary (CHO) shake flask experiments to the ambr® 250, and Expression of recombinant antibodies in Leishmania tarentolae. Provides the authority and expertise of leading contributors from an international board of authors Presents the latest release in the Methods in Enzymology serial Updated release includes the latest information on Recombinant Protein Expression
Download or read book Antibodies written by G. Subramanian and published by Springer Science & Business Media. This book was released on 2013-03-07 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: If the antibody industry is to achieve its full potential in the next decade, the individual technical potentials must be exploited, the limitations must be addressed, and lessons learned must be applied both to current purification methods and to the new technologies that continue to emerge. This book presents an overview of the current advances applied in the manufacture of monoclonal antibody including: -concepts in development of manufacturing strategies, -importance of antibody fragments, -application of chromatography method development, -quality control, -effect of expression on antibody properties, -virus removal and safety, -pharmacokinetics, -regulatory aspects.
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.
Download or read book Rapid Large Scale Production of Full Length Human Like Monoclonal Antibodies written by Christopher M. Warner and published by . This book was released on 2012 with total page 140 pages. Available in PDF, EPUB and Kindle. Book excerpt: Current recombinant protein production systems require several months to develop. Existing systems fail to provide timely, flexible, and cost-effective therapies to protect against emergency mass-casualty infections or poisonings. As the identity of many new biological threat agents are unlikely to be known in advance, pre-emptive manufacturing and stockpiling of countermeasures cannot be performed. Preparedness for a biological catastrophe requires a radical solution to replace the current slow scale-up and manufacture of lifesaving medical countermeasures. Subunit vaccines and antibody fragments may be produced in bacteria, yeast, plant or insect cells. However, generation of full-length, human like glycosylated antibodies requires mammalian cell culture due to the cell’s ability to carry out complex assembly and processing. Although commercial cell culture methods for antibody production from stable gene expression have been substantially improved over the last 30 years, the time required to achieve full scale production for a new product is too long for a rapid, emergency response. An alternative method for rapid production of high quality antibody protein is transient gene expression. Transient gene expression is an established, routine approach to small scale, researchgrade material of recombinant proteins. It is frequently used to generate gram quantities of material within weeks of lead target identification. In the past, transient gene expression has been considered for emergency production of large production of antibodies, but dismissed due to low titers, high DNA requirements, uncertain regulations, unavailable manufacturing capacity, and uncertain scale-up performance. If these barriers can be overcome in the next few years, emergency use of transient gene expression for production of life saving medical countermeasures would be a viable means to help protect our nation from biological attacks. The goal of this thesis is to investigate both the technical and operational feasibility of scaling up transient gene expression. In order to investigate the technical feasibility of such a method, a phenomenological understanding of transfection was developed for process characterization, process optimization and scale-up studies. Experiments in shaker flasks and lab-scale bioreactors interrogated a number of factors involved in the transfection process and identified an optimal design space for performing transfections (Chapters 2 and 3). Important factors that were identified include cell/DNA/PEI ratio, transfection incubation time, and agitation set points. Through this optimization process, the highest reported titer (>300 mg/L) in transient CHO production was achieved. Experimental transfections also provided calibration metrics for phenomenological models of mass transfer in very large bioreactors. These models were used to investigate the potential of mass transfer limitations upon scale-up (Chapter 2). The results indicate that, with appropriate design of the agitation systems, including consideration of the impact of mass transfer of PEI/DNA complexes from the medium to the cells during the transfection stage, scale-up should be successful. In the final stage of experimentation, successful identification of scalable systems for aseptic liquid-cell separation eliminated other potential bottlenecks that may be encountered during scale-up (Chapter 3). A novel combination of existing technology generated simplified transfection protocols, which may be commercialized for alternative markets. Operational feasibility was investigated through a survey of current manufacturing capacity for mammalian cell culture and their capabilities to provide meaningful emergency production of antibody countermeasures. Process simulation was conducted to analyze process flow, plant design, and cost for large scale production of both plasmid DNA (Chapter 5), a sub-component of transient gene expression, as well as antibody protein (Chapter 4). Simulations predicted that a 1,000-L fermentor would produce sufficient plasmid DNA at a cost of approximately $377/gram. This DNA could be utilized in a 200,000-L facility to produce between 32 and 1,274 kg of recombinant antibody. Experimentally validated transfection processes were then used to refine simulations. Subsequent simulation resulted in production of 197 kg within 3 months at a cost of 705 $/gram mAb. These simulations predict that largescale transient gene expression can provide sufficient lifesaving countermeasures if titer improvements are possible and can be successfully scaled to large bioreactors. This thesis demonstrates both the operational and technical feasibility of a successful large-scale transient gene expression platform for the production of full-length, human-like glycosylated antibodies as medical countermeasures for biological catastrophe. This approach is one critical component of our Nation’s arsenal of bio-defense capabilities.
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.
Download or read book Antibody Expression and Production written by Mohamed Al-Rubeai and published by Springer. This book was released on 2011-05-18 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: Engineered antibodies currently represent over 30% of biopharmaceuticals in clinical trials and their total worldwide sales continue to increase significantly. The importance of antibody applications is reflected in their increasing clinical and industrial applications as well as in the progression of established and emerging production strategies. This volume provides detailed coverage of the generation, optimization, characterization, production and applications of antibody. It provides the necessary theoretical background and description of methods for the expression of antibody in microbial and animal cell cultures and in transgenic animals and plants. There is a strong focus on those issues related to the production of intrabodies, bispecific antibody and antibody fragments and also to novel applications in cancer immunotherapy.
Download or read book Applications And Engineering Of Monoclonal Antibodies written by David J. King and published by CRC Press. This book was released on 1998-11-27 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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
Download or read book Cell Engineering written by Mohamed Al-Rubeai and published by Springer Science & Business Media. This book was released on 1999-06-30 with total page 311 pages. Available in PDF, EPUB and Kindle. Book excerpt: Integrating advances in molecular biology into bioprocesses presents a continuous challenge to scientists and bioengineers. This series is conceived to help meet this challenge. It examines and assesses the feasibility of new approaches for the modification of cellular function such as gene expression, protein processing, secretion, glycosylation, immortalisation, proliferation, and apoptosis as well as the systematic study of the metabolic genotype-phenotype relationship. The series provides detailed coverage of the methodology for improving cellular properties of cells used in the production of biopharmaceuticals, gene and cell therapies and tissue engineering. It also seeks to explain the cellular mechanisms underlying in vitro physiological activity and productivity. This volume, which is based on presentations at the `European Workshop on Animal Cell Engineering' held in Costa Brava, Spain, contains a collection of chapters relating to cellular function and modification by leading authorities in several different areas of basic research and the biopharmaceutical industry.
Download or read book Janeway s Immunobiology written by Kenneth Murphy and published by Garland Science. This book was released on 2010-06-22 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The Janeway's Immunobiology CD-ROM, Immunobiology Interactive, is included with each book, and can be purchased separately. It contains animations and videos with voiceover narration, as well as the figures from the text for presentation purposes.
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
Download or read book Antibody Engineering written by Carl A. K. Borrebaeck and published by Breakthroughs in Molecular Biology. This book was released on 1995 with total page 410 pages. Available in PDF, EPUB and Kindle. Book excerpt: In presenting a practical overview of the engineering of recombinant human or mouse monoclonal antibodies, the book incisively addresses essential topics such as antibody structure relevant to engineering, recombinatorial cDNA libraries, phage display, synthetic and humanized antibodies, engineering of affinity and biological effector functions, and plant, mammalian, and bacterial expression vectors and hosts. Antibody Engineering, Second Edition - written by leading experts and now thoroughly updated - is a unique resource for current information on the subject.
Download or read book Antibodies written by G. Subramanian and published by Springer Science & Business Media. This book was released on 2004-03-31 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is now over one hundred years since von Behring and Kitsato first concluded experiments that led to the use of passive immunisation, employing antibodies raised in animals against tetanus and diphtheria toxins. The advancement of technology both in manufacturing purity product in a cost effective way and the clinical research has proved that antibodies are one ofthe most successful products in biotechnology. Monoclonal antibodies account for between one-third and one-halfof all pharmaceutical products in development and human clinical trials. Both the nature of monoclonal antibody therapies and the relatively large size of the monoclonal antibody dictate the production requirements, for many ofthese therapeutics the monoclonal antibody product will be 100 kilogrammes or more per year. It is widely acknowledged that there is currently a worldwide shortage of biomanufacturing capacity, and the active pharmaceutical ingredient material requirements for these products are expected to increase. Thus the industry is looking for new sources and extensive studies are being carried out not only for alternative technology to meet the needs but also to reveal the new therapeutic applicationsofantibodies. This book brings to the forefront current advances in novel technologies for the manufacturing of monoclonal antibodies and also their extensive clinical importance. The first four chapters give an overview of the new technologies and the successful application in the manufacture of monoclonal antibodies with clinical purity. The next chapters address the application of antibodies in cancer therapy and functional genomic therapy.
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.
Download or read book Non Natural Amino Acids written by and published by Academic Press. This book was released on 2009-07-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: By combining the tools of organic chemistry with those of physical biochemistry and cell biology, Non-Natural Amino Acids aims to provide fundamental insights into how proteins work within the context of complex biological systems of biomedical interest. The critically acclaimed laboratory standard for 40 years, Methods in Enzymology is one of the most highly respected publications in the field of biochemistry. Since 1955, each volume has been eagerly awaited, frequently consulted, and praised by researchers and reviewers alike. With more than 400 volumes published, each Methods in Enzymology volume presents material that is relevant in today's labs -- truly an essential publication for researchers in all fields of life sciences. - Demonstrates how the tools and principles of chemistry combined with the molecules and processes of living cells can be combined to create molecules with new properties and functions found neither in nature nor in the test tube - Presents new insights into the molecular mechanisms of complex biological and chemical systems that can be gained by studying the structure and function of non-natural molecules - Provides a "one-stop shop" for tried and tested essential techniques, eliminating the need to wade through untested or unreliable methods
