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Detection and Quantification of Antibodies to Biopharmaceuticals

2011-07-12 Medical
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Release : 2011-07-12
Genre : Medical
Kind : eBook
Book Rating : 676/5 ( reviews)

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Book Synopsis Detection and Quantification of Antibodies to Biopharmaceuticals by : Michael G. Tovey

Download or read book Detection and Quantification of Antibodies to Biopharmaceuticals written by Michael G. Tovey. This book was released on 2011-07-12. Available in PDF, EPUB and Kindle. Book excerpt: The definitive book on the neutralization of recombinant biopharmaceuticals Recombinant biopharmaceuticals are an important tool for treating a range of illnesses; however, their efficacy can be severely impaired by their immunogenicity. When introduced into the body, these pharmaceuticals can cause the immune system to produce anti-drug antibodies (ADAs) that neutralize their effects. The first and only book to cover neutralization in connection with biopharmaceuticals and the measurement and application of neutralizing antibodies in modern medicine at any real length, Detection and Quantification of Antibodies to Biopharmaceuticals: Practical and Applied Considerations offers a comprehensive and in-depth look at all the principal aspects of the detection and quantification of antibodies that are essential to understanding and responding to the challenges they present. Bringing together a large-scale review of neutralization and biopharmaceuticals and the ability to measure, detect, and apply antibodies to modern science and medicine with international regulatory perspectives, the expectations of regulatory authorities, and the strengths and weaknesses of various assays, the book describes several novel ideas for detecting ADAs. Designed to serve as a resource for biopharmaceutical drug development, the book provides biotechnology companies and pharmaceutical drug development specialists, as well as non-experts, with key insights into the design, optimization, and qualification of assays, the establishment of sampling strategies, the choice of appropriate assay end-points, and data analysis for the detection and quantification of neutralizing antibodies.

Monoclonal Antibodies

2021-08-03 Medical
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Release : 2021-08-03
Genre : Medical
Kind : eBook
Book Rating : 197/5 ( reviews)

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Book Synopsis Monoclonal Antibodies by : Harleen Kaur

Download or read book Monoclonal Antibodies written by Harleen Kaur. This book was released on 2021-08-03. Available in PDF, EPUB and Kindle. Book excerpt: Monoclonal antibodies (mAbs) are naturally occurring complex biomolecules. New engineering methods have turned mAbs into a leading therapeutic modality for addressing immunotherapeutic challenges and led to the rise of mAbs as the dominant class of protein therapeutics. mAbs have already demonstrated a great potential in developing safe and reliable treatments for complex diseases and creating more affordable healthcare alternatives. Developing mAbs into well-characterized antibody therapeutics that meet regulatory expectations, however, is extremely challenging. Obstacles to overcome include the determination and development of physiochemical characteristics such as aggregation, fragmentation, charge variants, identity, carbohydrate structure, and higher-order structure (HOS). This book dives deep into mAbs structure and the array of physiochemical testing and characterization methods that need to be developed and validated to establish a mAb as a therapeutic molecule. The main focus of this book is on physiochemical aspects, including the importance of establishing quality attributes such as glycosylation, primary sequence, purity, and HOS and elucidating the structure of new antibody formats by mass spectrometry. Each of the aforementioned quality attributes has been discussed in detail; this will help scientists in researching and developing biopharmaceuticals and biosimilars to find practical solutions to physicochemical testing and characterization. - Describes the spectrum of analytical tests and characterization methods necessary for developing and releasing mAb batches - Details antibody heterogeneity in terms of size, charge, and carbohydrate content - Gives special focus to the structural analysis of mAbs, including mass spectrometry analysis - Presents the basic structure of mAbs with clarity and rigor - Addresses regulatory guidelines - including ICH Q6B - in relation to quality attributes - Lays out characterization and development case studies including biosimilars and new antibody formats

Drug Development and Safety

2024-07-10 Medical
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Release : 2024-07-10
Genre : Medical
Kind : eBook
Book Rating : 318/5 ( reviews)

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Book Synopsis Drug Development and Safety by :

Download or read book Drug Development and Safety written by . This book was released on 2024-07-10. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a detailed overview covering all aspects of drug development, from synthesis and manufacturing to delivery strategies, and ensuring a thorough understanding of the field. This book will show how new drugs are made. The chapters also give inside information on regulatory authorities so that drugs meet the necessary standards for quality. Drug Development and Safety effortlessly switches over to drug delivery technologies by exploring ground-breaking methods that are changing medicine forever. Controlled-release drug delivery systems represent some of the current breakthroughs while using nanoparticles for treating cancer stands among other recent therapeutic innovations. Each chapter has been authored by a leading scientist or expert in that particular field, and various viewpoints will be presented to provide a fuller understanding of the subjects concerning the safety of drugs. The book will be for chemists, pharmacists, and biologists, and it will be their only guide while navigating the challenging pharmaceutical science terrain.

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

2016-06-24 Medical
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Release : 2016-06-24
Genre : Medical
Kind : eBook
Book Rating : 293/5 ( reviews)

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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. This book was released on 2016-06-24. Available in PDF, EPUB and Kindle. Book excerpt: "Distributed in print by Oxford University Press."

Biopharmaceuticals

2020-12-07 Medical
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Release : 2020-12-07
Genre : Medical
Kind : eBook
Book Rating : 149/5 ( reviews)

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Book Synopsis Biopharmaceuticals by : Basanta Behera

Download or read book Biopharmaceuticals written by Basanta Behera. This book was released on 2020-12-07. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals: Challenges and Opportunities This book highlights how the traditional microbial process technology has been upgraded for the production of biologic drugs how manufacturing processes have evolved to meet the global market demand with quality products under the guidelines of internally recognized regulatory bodies. It also carries information on how, armed with a deeper understanding of life-threatening diseases, biopharmaceutical companies and the life sciences industry have developed formal and informal partnerships with researchers in institutes, universities, and other R&D organizations to fulfil timely, quality production with perfect safety and security. One of the most interesting aspects of this book is the conceptual development of personalized medicine (or precision medicine) to provide the right treatment to the right patient, at the right dose at an earlier stage of development, for genetic diseases. Besides this, it also highlights the most challenging aspects of modern biopharmaceutical science, focusing on the hot topics such as design and development of biologic drugs; the use of diversified groups of host cells belonging to animals, plants, microbes, insects, and mammals; stem cell therapy and gene therapy; supply chain management of biopharmaceuticals; and the future scope of biopharmaceutical industry development. This book is the latest resource for a wide circle of scientists, students, and researchers involved in understanding and implementing the knowledge of biopharmaceuticals to develop life-saving biologic drugs and to bring awareness to the development of personalized treatment that can potentially offer patients a faster diagnosis, fewer side effects, and better outcomes. Features: Explains how the traditional cell culture methodology has been changed to a fully continuous or partially continuous process Explains how to design and fabricate living organs of body by 3D bioprinting technology Focuses on how a biopharmaceutical company deals with various problems of regulatory bodies and develops innovative biologic drugs Narrates in detail the updated information on stem cell therapy and gene therapy Explains the development strategies and clinical significance of biosimilars and biobetters Highlights the supply chain management of biopharmaceuticals

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