Monoclonal Antibodies Book

Monoclonal Antibodies


  • Author : Steven Shire
  • Publisher : Woodhead Publishing
  • Release Date : 2015-04-24
  • Genre: Medical
  • Pages : 224
  • ISBN 10 : 9780081002971
  • Total Read : 93
  • File Size : 20,6 Mb

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Monoclonal Antibodies Summary:

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

Formulation of Monoclonal Antibody Therapies Book

Formulation of Monoclonal Antibody Therapies


  • Author : Amal Ali Elkordy
  • Publisher : Academic Press
  • Release Date : 2021-10-15
  • Genre: Business & Economics
  • Pages : 245
  • ISBN 10 : 0128233656
  • Total Read : 85
  • File Size : 8,6 Mb

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Formulation of Monoclonal Antibody Therapies Summary:

Formulation of Monoclonal Antibody Therapies: From Lab to Market covers a wide range of topics about therapeutic monoclonal antibodies (mAbs) with a focus on formulation aspects. Therapeutic monoclonal antibodies are used for treatment of chronic diseases. It brings together a comprehensive knowledge in one accessible volume. Starting with foundational information on monoclonal antibodies, the book then discusses the importance of biopharmaceutical products, monoclonal antibodies and biosimilars in treatment of chronic diseases, pharmaceutical aspects of mAbs, and how it can be administered. The industrial point of view and the clinical application of mAbs including in oncology, general medicine, rheumatology, hematology, dermatology, gastrointestinal tract, metabolic diseases and dentistry. Formulation of Monoclonal Antibody Therapies: From Lab to Market is essential reading for researchers in biotechnology and biopharmaceutical fields, academics and pharmaceutical industrial scientists, and university students in pharmaceutical and biopharmaceutical sciences. Covers details of recent advances in using mAbs Examines how to overcome the challenges for formulations of therapeutic mAbs Includes liposomal forms of mAbs

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
  • Total Read : 82
  • File Size : 18,5 Mb

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Monoclonal Antibody Production Summary:

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.

Bioconjugate Techniques Book
Score: 5
From 1 Ratings

Bioconjugate Techniques


  • Author : Greg T. Hermanson
  • Publisher : Academic Press
  • Release Date : 2013-07-25
  • Genre: Science
  • Pages : 1200
  • ISBN 10 : 9780123822406
  • Total Read : 96
  • File Size : 7,7 Mb

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Bioconjugate Techniques Summary:

Bioconjugate Techniques, 3rd Edition, is the essential guide to the modification and cross linking of biomolecules for use in research, diagnostics, and therapeutics. It provides highly detailed information on the chemistry, reagent systems, and practical applications for creating labeled or conjugate molecules. It also describes dozens of reactions, with details on hundreds of commercially available reagents and the use of these reagents for modifying or crosslinking peptides and proteins, sugars and polysaccharides, nucleic acids and oligonucleotides, lipids, and synthetic polymers. Offers a one-stop source for proven methods and protocols for synthesizing bioconjugates in the lab Provides step-by-step presentation makes the book an ideal source for researchers who are less familiar with the synthesis of bioconjugates Features full color illustrations Includes a more extensive introduction into the vast field of bioconjugation and one of the most thorough overviews of immobilization chemistry ever presented

Development of Biopharmaceutical Drug Device Products Book

Development of Biopharmaceutical Drug Device Products


  • Author : Feroz Jameel
  • Publisher : Springer Nature
  • Release Date : 2020-03-13
  • Genre: Medical
  • Pages : 893
  • ISBN 10 : 9783030314156
  • Total Read : 78
  • File Size : 17,9 Mb

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Development of Biopharmaceutical Drug Device Products Summary:

The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytica

Immunologic Concepts in Transfusion Medicine Book

Immunologic Concepts in Transfusion Medicine


  • Author : Robert W Maitta
  • Publisher : Elsevier Health Sciences
  • Release Date : 2019-08-27
  • Genre: Medical
  • Pages : 380
  • ISBN 10 : 9780323675109
  • Total Read : 76
  • File Size : 12,5 Mb

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Immunologic Concepts in Transfusion Medicine Summary:

Immunological Concepts in Transfusion Medicine provides a thorough discussion of the immune aspects of blood component transfusion, with in-depth information on the intricacies of immune responses to blood components and the immune processes that may be initiated in response to blood exposure. Written to increase knowledge and awareness of immune challenges such as alloimmunization and transfusion-related acute lung injury, this title bridges current basic scientific discoveries and the potential effects seen in blood recipients. Complies the knowledge and expertise of Dr. Robert Maitta, an expert in immune responses and antibody function/structure studies. Helps clinicians in the daily practice of caring for patients in need of transfusion support, as well as physicians in training when considering utilizing blood transfusions in a limited scope or in the setting of massive transfusion. Includes an immunology primer as an introduction to in-depth chapters covering allergic immune reactions to blood components, transfusion-related immunomodulation, fetal and neonatal alloimmune thrombocytopenia and neonatal neuthropenia, complications of haploidentical and mismatched HSC transplantation, chimeric antibody receptor therapies, and much more. Consolidates today’s available information on this timely topic into a single, convenient resource.

Current Trends in Monoclonal Antibody Development and Manufacturing Book

Current Trends in Monoclonal Antibody Development and Manufacturing


  • Author : Steven J. Shire
  • Publisher : Springer Science & Business Media
  • Release Date : 2009-11-11
  • Genre: Medical
  • Pages : 354
  • ISBN 10 : 038776643X
  • Total Read : 92
  • File Size : 9,7 Mb

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Current Trends in Monoclonal Antibody Development and Manufacturing Summary:

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.

From Clone to Clinic Book

From Clone to Clinic


  • Author : Daan J.A. Crommelin
  • Publisher : Springer Science & Business Media
  • Release Date : 2012-12-06
  • Genre: Medical
  • Pages : 379
  • ISBN 10 : 9789401137805
  • Total Read : 73
  • File Size : 17,5 Mb

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From Clone to Clinic Summary:

This book contains a selection of the papers presented at the meeting "Between Clone and Clinic" which was organised in March 1990 in Amsterdam by the dutch Organisation for Applied Research, TNO, and the University of Utrecht. The scope of this meeting was the development of biotechnological pharmaceuticals mainly made by recombinant DNA technology or monoclonal antibody techniques. All aspects concerning the development of the products after host cells producing them are obtained where discussed. The meeting was attended by twohundred specialists from all over the globe, including phar macologists, toxicologists, registration experts, Quality Assurence managers, production en gineers and physicians. Biotechnological pharmaceuticals are in general large and complex protein molecules. Bringing these products to the market poses other problems than encountered with the classical chemical drugs. The source of biotechnological pharmaceuticals are living cells. The function of cells are depend ent on many factors and the stability of production may be a problem. Good Laboratory and Manufactory Practices with Quality Control (GLP and GMP) are of paramount importance and are discussed in a number of papers. The products of the new biotechnology are often highly specific and only active in the human species. Also the side effects can only be studied in the clinical setting. Even when the product is active in animals there is the problem of antigenicity. During treatment the animals will produce antibodies which neutralise the activity. So safety testing may prove difficult.