Immunogenicity Of Biopharmaceuticals In Chronic Inflammatory Diseases

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Immunogenicity of Biopharmaceuticals

Author : Marco Weert,Eva Horn Møller
Publisher : Springer Science & Business Media
Page : 266 pages
File Size : 44,8 Mb
Release : 2008-02-06
Category : Medical
ISBN : 9780387758411

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Immunogenicity of Biopharmaceuticals by Marco Weert,Eva Horn Møller Pdf

Immunogenicity of Biopharmaceuticals is the first book to comprehensively address the potential of an immune response to biopharmaceuticals. It is intended to give a broad overview of the current state-of-the-art regarding this subject. The chapters range from an overview of the immune system and factors that may trigger the immune system, via detection of antibodies and clinical implications, to various case examples and the regulatory view on immunogenicity.

Immunogenicity of Proteins Used as Therapeutics

Author : Amy Rosenberg,Zuben E. Sauna,Bernard Maillere,Susan Richards,Elizabeth C. Jury
Publisher : Frontiers Media SA
Page : 328 pages
File Size : 42,9 Mb
Release : 2020-12-28
Category : Medical
ISBN : 9782889662883

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Immunogenicity of Proteins Used as Therapeutics by Amy Rosenberg,Zuben E. Sauna,Bernard Maillere,Susan Richards,Elizabeth C. Jury Pdf

Topic Editor Susan Richards is an employee of Sanofi and owns stock in the corporation. Topic Editor Bernard Maillere declares economic support from pharmaceutical companies (Novartis, Sanofi, and UCB) in the frame of collaborations aiming to evaluate the recognition by human T cells of therapeutic proteins and antibodies.

Adverse Reactions to Biologics

Author : L. Puig,W. Gulliver
Publisher : Karger Medical and Scientific Publishers
Page : 120 pages
File Size : 43,8 Mb
Release : 2017-11-07
Category : Medical
ISBN : 9783318061017

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Adverse Reactions to Biologics by L. Puig,W. Gulliver Pdf

In many areas of medicine physicians still face the great challenge of finding therapies that will meet the patients’ needs. In dermatology the challenge has arisen on multiple fronts through advances in the understanding of the immunopathogenesis of many inflammatory and malignant cutaneous disorders. Breakthroughs, combined with significant developments in targeted immunotherapy, have resulted in improved outcomes as these newer therapies are being used for both approved indications and as off-label therapies for various chronic inflammatory skin disorders and many forms of skin cancer. In the expectation that by truly understanding the safety profile of these targeted therapies patients’ outcomes will be significantly improved, this book offers insights into topics such as adverse reactions, infectious complications and the perioperative use of biologics in psoriasis, immunogenicity of biologic therapies, paradoxical reactions, safety of biologics used to treat autoimmune bullous diseases and primary cutaneous lymphomas, adverse reactions and skin manifestations of therapies targeting melanoma and non-melanoma skin cancer and other neoplastic diseases. Eminent researchers with extensive clinical experience have contributed to this publication, providing an in-depth overview of the latest knowledge in this field.

Immunologic Concepts in Transfusion Medicine

Author : Robert W Maitta
Publisher : Elsevier Health Sciences
Page : 380 pages
File Size : 54,5 Mb
Release : 2019-08-27
Category : Medical
ISBN : 9780323675109

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Immunologic Concepts in Transfusion Medicine by Robert W Maitta Pdf

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.

Biotechnology and Biopharmaceuticals

Author : Anonim
Publisher : John Wiley & Sons
Page : 744 pages
File Size : 52,9 Mb
Release : 2013-12-16
Category : Science
ISBN : 9781118179796

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Biotechnology and Biopharmaceuticals by Anonim Pdf

Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

Pharmaceutical Biotechnology

Author : Daan J. A. Crommelin,Robert D. Sindelar,Bernd Meibohm
Publisher : Springer
Page : 653 pages
File Size : 42,9 Mb
Release : 2019-04-13
Category : Medical
ISBN : 9783030007102

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Pharmaceutical Biotechnology by Daan J. A. Crommelin,Robert D. Sindelar,Bernd Meibohm Pdf

This introductory text explains both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use. It serves as a complete one-stop source for undergraduate/graduate pharmacists, pharmaceutical science students, and for those in the pharmaceutical industry. The Fifth Edition completely updates the previous edition, and also includes additional coverage on the newer approaches such as oligonucleotides, siRNA, gene therapy and nanotech and enzyme replacement therapy.

Fusion Protein Technologies for Biopharmaceuticals

Author : Stefan R. Schmidt
Publisher : John Wiley & Sons
Page : 995 pages
File Size : 52,5 Mb
Release : 2013-01-28
Category : Medical
ISBN : 9781118354582

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Fusion Protein Technologies for Biopharmaceuticals by Stefan R. Schmidt Pdf

The state of the art in biopharmaceutical FUSION PROTEIN DESIGN Fusion proteins belong to the most lucrative biotech drugs—with Enbrel® being one of the best-selling biologics worldwide. Enbrel® represents a milestone of modern therapies just as Humulin®, the first therapeutic recombinant protein for human use, approved by the FDA in 1982 and Orthoclone® the first monoclonal antibody reaching the market in 1986. These first generation molecules were soon followed by a plethora of recombinant copies of natural human proteins, and in 1998, the first de novo designed fusion protein was launched. Fusion Protein Technologies for Biopharmaceuticals examines the state of the art in developing fusion proteins for biopharmaceuticals, shedding light on the immense potential inherent in fusion protein design and functionality. A wide pantheon of international scientists and researchers deliver a comprehensive and complete overview of therapeutic fusion proteins, combining the success stories of marketed drugs with the dynamic preclinical and clinical research into novel drugs designed for as yet unmet medical needs. The book covers the major types of fusion proteins—receptor-traps, immunotoxins, Fc-fusions and peptibodies—while also detailing the approaches for developing, delivering, and improving the stability of fusion proteins. The main body of the book contains three large sections that address issues key to this specialty: strategies for extending the plasma half life, the design of toxic proteins, and utilizing fusion proteins for ultra specific targeting. The book concludes with novel concepts in this field, including examples of highly relevant multifunctional antibodies. Detailing the innovative science, commercial realities, and brilliant potential of fusion protein therapeutics, Fusion Protein Technologies for Biopharmaceuticals is a must for pharmaceutical scientists, biochemists, medicinal chemists, molecular biologists, pharmacologists, and genetic engineers interested in determining the shape of innovation in the world of biopharmaceuticals.

Mucosal Vaccines

Author : Hiroshi Kiyono
Publisher : Elsevier
Page : 479 pages
File Size : 48,8 Mb
Release : 1996-10-23
Category : Medical
ISBN : 0080537057

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Mucosal Vaccines by Hiroshi Kiyono Pdf

This comprehensive, authoritative treatise covers all aspects of mucosal vaccines including their development, mechanisms of action, molecular/cellular aspects, and practical applications. The contributing authors and editors of this one-of-a-kind book are very well known in their respective fields. Mucosal Vaccines is organized in a unique format in which basic, clinical, and practical aspects of the mucosal immune system for vaccine development are described and discussed. This project is endorsed by the Society for Mucosal Immunology. Provides the latest views on mucosal vaccines Applies basic principles to the development of new vaccines Links basic, clinical, and practical aspects of mucosal vaccines to different infectious diseases Unique and user-friendly organization

Detection and Quantification of Antibodies to Biopharmaceuticals

Author : Michael G. Tovey
Publisher : John Wiley & Sons
Page : 316 pages
File Size : 44,5 Mb
Release : 2011-07-12
Category : Medical
ISBN : 9781118075678

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Detection and Quantification of Antibodies to Biopharmaceuticals by Michael G. Tovey Pdf

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.

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

Author : Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard Weinbauer
Publisher : Academic Press
Page : 716 pages
File Size : 42,6 Mb
Release : 2015-03-13
Category : Medical
ISBN : 9780124171466

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The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment by Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard Weinbauer Pdf

The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area. Covers important topics such as species selection, study design, experimental methodologies, animal welfare and the 3Rs (Replace, Refine and Reduce), social housing, regulatory guidelines, comparative physiology, reproductive biology, genetic polymorphisms and more Includes practical examples on techniques and methods to guide your daily practice Offers a companion website with high-quality color illustrations, reference values for safety assessment and additional practical information such as study design considerations, techniques and procedures and dosing and sampling volumes

Drug Hypersensitivity

Author : Werner J. Pichler
Publisher : Karger Medical and Scientific Publishers
Page : 440 pages
File Size : 42,9 Mb
Release : 2007-01-01
Category : Medical
ISBN : 9783805582698

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Drug Hypersensitivity by Werner J. Pichler Pdf

Approaches the phenomenon of drug hypersensitivity in a comprehensive manner. Besides epidemiological aspects, it addresses the immunological mechanisms underlying these complicated reactions which go far beyond the IgE-mediated drug allergies also considered in this book. The book also covers clinical manifestations and new diagnostic methods, and introduces some recetly established animal models. Many topics are treated from multiple perspectives, and the 33 chapters are thoroughly cross-referenced.

Oxford Textbook of Rheumatoid Arthritis

Author : David L. Scott,James Galloway,Andrew Cope,Arthur Pratt,Vibeke Strand
Publisher : Oxford University Press
Page : 576 pages
File Size : 44,7 Mb
Release : 2020-09-18
Category : Medical
ISBN : 9780192567116

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Oxford Textbook of Rheumatoid Arthritis by David L. Scott,James Galloway,Andrew Cope,Arthur Pratt,Vibeke Strand Pdf

This brand new textbook of rheumatoid arthritis (RA) is an important addition to the Oxford Textbooks in Rheumatology series, and provides a comprehensive overview of both the scientific and clinical aspects of the disease. Divided into eight sections - from the history, diagnosis, and epidemiology of the disease, through the pathogenesis, clinical presentation, and assessment to treatments and management strategies, both drug- and non-drug based - each chapter is written by leading clinicians and scientists in the field to deliver a contemporary view of RA. During the past two decades there have been revolutionary changes in the understanding and management of rheumatoid arthritis, in particular the development of biological treatments. This has had wide-ranging effects on almost all aspects of treatment, from effectiveness and intensity to the nature and the cost. Providing a comprehensive account of the modern ideas about the disease, the Oxford Textbook of Rheumatoid Arthritis is a key new addition to the literature, with each chapter providing a detailed background, key recent advances, and areas of doubt and future developments. Featuring over 170 photographs, radiological images, and clinical charts to aid both diagnosis and illustrate the rationale behind key scientific studies, this new title will prove an indispensable resource for specialist rheumatologists, trainees in rheumatology, and other members of the multi-disciplinary team.

Biologics, Biosimilars, and Biobetters

Author : Iqbal Ramzan
Publisher : John Wiley & Sons
Page : 328 pages
File Size : 51,8 Mb
Release : 2021-02-03
Category : Medical
ISBN : 9781119564652

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Biologics, Biosimilars, and Biobetters by Iqbal Ramzan Pdf

A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists

Preclinical Safety Evaluation of Biopharmaceuticals

Author : Joy A. Cavagnaro
Publisher : John Wiley & Sons
Page : 1012 pages
File Size : 47,9 Mb
Release : 2013-03-07
Category : Medical
ISBN : 9781118679388

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Preclinical Safety Evaluation of Biopharmaceuticals by Joy A. Cavagnaro Pdf

"The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals Covers transitioning from preclinical development to clinical trials This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel.

Pharmaceutical Biotechnology

Author : Daan J. A. Crommelin,Robert D. Sindelar
Publisher : CRC Press
Page : 456 pages
File Size : 51,7 Mb
Release : 2002-11-14
Category : Medical
ISBN : 0415285011

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Pharmaceutical Biotechnology by Daan J. A. Crommelin,Robert D. Sindelar Pdf

The field of pharmaceutical biotechnology is evolving rapidly. A whole new arsenal of protein pharmaceuticals is being produced by recombinant techniques for cancer, viral infections, cardiovascular and hereditary disorders, and other diseases. In addition, scientists are confronted with new technologies such as polymerase chain reactions, combinatorial chemistry and gene therapy. This introductory textbook provides extensive coverage of both the basic science and the applications of biotechnology-produced pharmaceuticals, with special emphasis on their clinical use. Pharmaceutical Biotechnology serves as a complete one-stop source for undergraduate pharmacists, and it is valuable for researchers and professionals in the pharmaceutical industry as well.