Immunogenicity Of Therapeutic Biological Products

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Adverse Reactions to Biologics

Author : L. Puig
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 3318061018
Total Pages : 120 pages
Book Rating : 4.3/5 (18 download)

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Book Synopsis Adverse Reactions to Biologics by : L. Puig

Download or read book Adverse Reactions to Biologics written by L. Puig and published by Karger Medical and Scientific Publishers. This book was released on 2017-11-07 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Immunogenicity of Therapeutic Biological Products

Author : Fred Brown
Publisher : S. Karger AG (Switzerland)
ISBN 13 :
Total Pages : 196 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Immunogenicity of Therapeutic Biological Products by : Fred Brown

Download or read book Immunogenicity of Therapeutic Biological Products written by Fred Brown and published by S. Karger AG (Switzerland). This book was released on 2003 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt: Immune responses to biological products have occurred with many approved therapeutics. The proportion of patients mounting an immune response is product dependent and the clinical significance of the immune response also varies with the nature of the product. Some products can induce production of significant levels of antibodies without any detectable effect on the activity of the product. However, neutralizing antibodies can attenuate the efficacy of the treatment and significant adverse clinical events can be seen if neutralizing antibodies cross-react with patients' endogenous proteins. Prediction of immunogenicity includes the use of bio-informatics to predict T-cell epitopes, T-cell stimulation assays and in vivo transgenic animal models. Approaches to prevent immunogenicity involve methods to design out immunogenic sequences, protein pegylation and inducing tolerance. Current methods for assessing and detecting immunogenicity include in vivo animal models, antibody assays and biological assays. The advantages and disadvantages of the various methods illustrate that a battery of tests is required to appropriately monitor patients' immune responses during clinical trials.

Immunogenicity of Proteins Used as Therapeutics

Author : Amy Rosenberg
Publisher : Frontiers Media SA
ISBN 13 : 2889662888
Total Pages : 328 pages
Book Rating : 4.8/5 (896 download)

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Book Synopsis Immunogenicity of Proteins Used as Therapeutics by : Amy Rosenberg

Download or read book Immunogenicity of Proteins Used as Therapeutics written by Amy Rosenberg and published by Frontiers Media SA. This book was released on 2020-12-28 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Safety of Biologics Therapy

Author : Brian A. Baldo
Publisher : Springer
ISBN 13 : 3319304720
Total Pages : 610 pages
Book Rating : 4.3/5 (193 download)

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Book Synopsis Safety of Biologics Therapy by : Brian A. Baldo

Download or read book Safety of Biologics Therapy written by Brian A. Baldo and published by Springer. This book was released on 2016-08-12 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Rare Diseases and Orphan Products

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine

Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Immunogenicity of Biopharmaceuticals

Author : Marco Weert
Publisher : Springer
ISBN 13 : 9781441926081
Total Pages : 0 pages
Book Rating : 4.9/5 (26 download)

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Book Synopsis Immunogenicity of Biopharmaceuticals by : Marco Weert

Download or read book Immunogenicity of Biopharmaceuticals written by Marco Weert and published by Springer. This book was released on 2010-11-19 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Drug Hypersensitivity

Author : Werner J. Pichler
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 3805582692
Total Pages : 440 pages
Book Rating : 4.8/5 (55 download)

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Book Synopsis Drug Hypersensitivity by : Werner J. Pichler

Download or read book Drug Hypersensitivity written by Werner J. Pichler and published by Karger Medical and Scientific Publishers. This book was released on 2007-01-01 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Biologics, Biosimilars, and Biobetters

Author : Iqbal Ramzan
Publisher : John Wiley & Sons
ISBN 13 : 1119564654
Total Pages : 328 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Biologics, Biosimilars, and Biobetters by : Iqbal Ramzan

Download or read book Biologics, Biosimilars, and Biobetters written by Iqbal Ramzan and published by John Wiley & Sons. This book was released on 2021-02-03 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Biologics and Biosimilars

Author : Xiaodong Feng
Publisher : CRC Press
ISBN 13 : 0429939280
Total Pages : 642 pages
Book Rating : 4.4/5 (299 download)

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Book Synopsis Biologics and Biosimilars by : Xiaodong Feng

Download or read book Biologics and Biosimilars written by Xiaodong Feng and published by CRC Press. This book was released on 2022-06-13 with total page 642 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biologics and Biosimilars: Drug Discovery and Clinical Applications is a systematic integration and evaluation of all aspects of biologics and biosimilars, encompassing research and development, clinical use, global regulation, and more. Biosimilars are biological therapeutic agents designed to imitate a reference biologic with high similarities in structure, efficacy, and safety, but also with potential clinical effective and cost-efficient options for the manufacturers, payers, clinicians, and patients. Most of the top-selling prescription drugs in the current market are biologics, which have revolutionized the treatment strategies and modalities for life-threatening and/or rare diseases. This book outlines the key processes and challenges in drug development, regulations, and clinical applications of biologics, biosimilars, and even interchangeable biosimilars. Global experts in the field discuss essential categories and prototype drugs of biologics and biosimilars in clinical practice such as allergenics, blood and blood components, cell treatment, gene therapy, recombinant therapeutic proteins or peptides, tissues, and vaccines. Additional features: Integrates the latest bench and bedside evidence of drug development and regulations of biologics and biosimilars Contains key study questions for each chapter to guide the readers, as well as drug charts for all therapeutic applications of biologics and biosimilars Presents detailed schematic illustrations to explain the drug development, clinical trials, regulations, and clinical applications of biologics and biosimilars This book is an invaluable tool for health care professional students, providers, and pharmaceutical and health care industries, as well as the public, providing readers with educational updates about the drug development and clinical affairs of biological medications and their similar drugs.

Safe and Effective Medicines for Children

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309225493
Total Pages : 432 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Safe and Effective Medicines for Children by : Institute of Medicine

Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

Protein Therapeutics, 2 Volume Set

Author : Tristan Vaughan
Publisher : John Wiley & Sons
ISBN 13 : 3527340866
Total Pages : 762 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Protein Therapeutics, 2 Volume Set by : Tristan Vaughan

Download or read book Protein Therapeutics, 2 Volume Set written by Tristan Vaughan and published by John Wiley & Sons. This book was released on 2017-12-04 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this practice-oriented two volume handbook, professionals from some of the largest biopharmaceutical companies and top academic researchers address the key concepts and challenges in the development of protein pharmaceuticals for medicinal chemists and drug developers of all trades. Following an introduction tracing the rapid development of the protein therapeutics market over the last decade, all currently used therapeutic protein scaffolds are surveyed, from human and non-human antibodies to antibody mimetics, bispecific antibodies and antibody-drug conjugates. This ready reference then goes on to review other key aspects such as pharmacokinetics, safety and immunogenicity, manufacture, formulation and delivery. The handbook then takes a look at current key clinical applications for protein therapeutics, from respiratory and inflammation to oncology and immune-oncology, infectious diseases and rescue therapy. Finally, several exciting prospects for the future of protein therapeutics are highlighted and discussed.

Immunogenicity of Therapeutic Biological Products

Author : Fred Brown
Publisher : S. Karger AG (Switzerland)
ISBN 13 : 9783805575751
Total Pages : 196 pages
Book Rating : 4.5/5 (757 download)

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Book Synopsis Immunogenicity of Therapeutic Biological Products by : Fred Brown

Bioanalytical Aspects in Biological Therapeutics

Author : Xiaohui (Sophia) Xu
Publisher : John Wiley & Sons
ISBN 13 : 1119523281
Total Pages : 404 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Bioanalytical Aspects in Biological Therapeutics by : Xiaohui (Sophia) Xu

Download or read book Bioanalytical Aspects in Biological Therapeutics written by Xiaohui (Sophia) Xu and published by John Wiley & Sons. This book was released on 2022-07-06 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bioanalytical Aspects in Biological Therapeutics Deepen your understanding of how critical data are generated from bioanalysis In Bioanalytical Aspects in Biological Therapeutics, a team of renowned chemists, immunologists, and biologists delivers a timely and practical exploration of the diverse scientific and technical literature on the bioanalytical investigation of current biotherapeutics under development. The book discusses the challenges and considerations for bioanalytical support, covering a wide range of central topics in the field, including overview and basic immunology for testing of biological therapeutics, pharmacokinetic aspects, clinical immunogenicity prediction and testing, biomarker testing, biotransformation assessment for biologics, statistical aspects of bioanalytical testing, regulatory expectations, and more. Drug development and analysis professionals will learn how critical data are generated from bioanalysis and how proven tools and methods are applied to the development of biologics. Alongside coverage of topics like PK, immunogenicity, neutralizing antibody assays, and the importance of quality control for reagents, readers will benefit from: A thorough overview of the development of biotherapeutics and the role played by bioanalytical tests, as well as basic immunology for bioanalytical testing of biological therapeutics Comprehensive explorations of platform and instrument considerations in bioanalytical testing, pharmacokinetics assays, and biomarker analysis using LC-MS, LBA, and other technologies Practical discussions of immunogenicity prediction, preclinical and clinical anti-drug antibody assays, and bioanalytical schemes for anti-drug neutralizing antibody assays In-depth examinations of critical reagents in bioanalysis Regulatory expectations for bioanalytical method development, validation, and sample testing Perfect for pharmaceutical scientists in industry, Bioanalytical Aspects in Biological Therapeutics will also earn a place in the libraries of pharmaceutical regulators and other professionals working in pharmaceutical companies, as well as graduate students studying bioanalytical assays for biological therapeutics.

Immunology for Pharmacy - E-Book

Author : Dennis Flaherty
Publisher : Elsevier Health Sciences
ISBN 13 : 0323291112
Total Pages : 272 pages
Book Rating : 4.3/5 (232 download)

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Book Synopsis Immunology for Pharmacy - E-Book by : Dennis Flaherty

Download or read book Immunology for Pharmacy - E-Book written by Dennis Flaherty and published by Elsevier Health Sciences. This book was released on 2014-06-25 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: With a new pharmacy-specific approach to immunology, Immunology for Pharmacy prepares pharmacists for practice by providing a complete understanding of the basis of immunology and the consequences of either suppressing or enhancing immune function. It covers key subjects such as prophylaxis and vaccination, antibodies as therapeutic and diagnostic agents, biological modifiers, and the rationale for use and mechanisms of therapeutic agents. Written by experienced author and educator Dennis Flaherty, this book presents topics with a logical, step-by-step approach, explaining concepts and their practical application. A companion Evolve website reinforces your understanding with flashcards and animations. Pharmacy-specific coverage narrows the broad field of immunology to those areas most pertinent and clinically relevant to pharmacy students. 165 full-color illustrations help to illuminate difficult concepts. Factors That Influence the Immune Response chapter covers biological agents including bacteria, viruses, and fungi, and their related toxins and how they relate to the immune system. Three chapters on vaccinations prepare you for this important part of the pharmacist's role by discussing cancer treatment with whole tumor vaccines, cell vaccines, and viral vector vaccines, describing other vaccines such as recombinant vaccines and plant vaccines, and examining how diseases such as diphtheria, whooping cough, and tetanus respond to vaccinations. A summary of drugs used in treating each condition helps you understand typical treatments and their immunological mechanisms, so you can choose proper treatments. Integrated information makes it easier to understand how various parts of the immune system work together, leading to a better understanding of immunology as a whole. A unique focus on practical application and critical thinking shows the interrelationship of concepts and makes it easier to apply theory to practice. Information on AIDS covers the identification and treatment of both strains of HIV as well as AIDS, preparing you for diseases you will see in practice. Unique student-friendly features simplify your study with learning objectives and key terms at the beginning of each chapter, bulleted summaries and self-assessment questions at the end of each chapter, and a glossary at the back of the book. Over 60 tables summarize and provide quick reference to important material. A companion Evolve website includes animations and pharmacy terminology flashcards.

Protein Therapeutics

Author : Zuben E. Sauna
Publisher : Springer
ISBN 13 : 9783319824376
Total Pages : 0 pages
Book Rating : 4.8/5 (243 download)

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Book Synopsis Protein Therapeutics by : Zuben E. Sauna

Download or read book Protein Therapeutics written by Zuben E. Sauna and published by Springer. This book was released on 2018-07-28 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of targets, drug design approaches, chemogenomics, synthetic chemistry including combinatorial methods, bioorganic chemistry, natural compounds, high-throughput screening, pharmacological in vitro and in vivo investigations, drug-receptor interactions on the molecular level, structure-activity relationships, drug absorption, distribution, metabolism, elimination, toxicology and pharmacogenomics. In general, special volumes are edited by well known guest editors

Therapeutic Antibody Engineering

Author : William R Strohl
Publisher : Elsevier
ISBN 13 : 1908818093
Total Pages : 697 pages
Book Rating : 4.9/5 (88 download)

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Book Synopsis Therapeutic Antibody Engineering by : William R Strohl

Download or read book Therapeutic Antibody Engineering written by William R Strohl and published by Elsevier. This book was released on 2012-10-16 with total page 697 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of antibody engineering has become a vital and integral part of making new, improved next generation therapeutic monoclonal antibodies, of which there are currently more than 300 in clinical trials across several therapeutic areas. Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on future candidates. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. Following chapters cover a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering. Goes beyond the standard engineering issues covered by most books and delves into structure-function relationships Integration of knowledge across all areas of antibody engineering, development, and marketing Discusses how current and future genetic engineering of cell lines will pave the way for much higher productivity

Peptide Therapeutics

Author : Ved Srivastava
Publisher : Royal Society of Chemistry
ISBN 13 : 1788014332
Total Pages : 572 pages
Book Rating : 4.7/5 (88 download)

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Book Synopsis Peptide Therapeutics by : Ved Srivastava

Download or read book Peptide Therapeutics written by Ved Srivastava and published by Royal Society of Chemistry. This book was released on 2019-08-28 with total page 572 pages. Available in PDF, EPUB and Kindle. Book excerpt: Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development of novel peptide drugs in the clinic is their deficiencies in clearly defined chemistry, manufacturing and controls (CMC) strategy from clinical development to commercialization. CMC can often become a rate-limiting step due to lack of knowledge and lack of a formal policy or guidelines on CMC for peptide-based drugs. Regulators use a risk-based approach, reviewing applications on a case-by-case basis. Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing, and Controls covers efficient manufacturing of peptide drug substances, a review of the process for submitting applications to the regulatory authority for drug approval, a holistic approach for quality attributes and quality control from a regulatory perspective, emerging analytical tools for the characterisation of impurities, and the assessment of stability. This book is an essential reference work for students and researchers, in both academia and industry, with an interest in learning about CMC, and facilitating development and manufacture of peptide-based drugs.