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.

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: Branchenführende Big-Pharma-Unternehmen und erstklassige Forscher präsentieren grundlegende Konzepte und Herausforderungen bei proteinbasierten Pharmazeutika. Beinhaltet auch eine Einführung in die aus Sicht der Arzneimittelentwicklung fünf wesentlichen Anwendungsbereiche.

Safety of Biologics Therapy

Author : Brian A. Baldo
Publisher : Springer
ISBN 13 : 3319304720
Total Pages : 623 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 623 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.

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.

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.

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.

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.

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.

Biosimilars

Author : Jean-Louis Prugnaud
Publisher : Springer Science & Business Media
ISBN 13 : 2817803361
Total Pages : 101 pages
Book Rating : 4.8/5 (178 download)

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Book Synopsis Biosimilars by : Jean-Louis Prugnaud

Download or read book Biosimilars written by Jean-Louis Prugnaud and published by Springer Science & Business Media. This book was released on 2012-11-27 with total page 101 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the “generic rule” valid for small chemical entities. In response, a dedicated regulation was issued in the European Union. It is based on the concept of “biological medicinal products similar to a biological reference product”, or “biosimilars”. This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. It highlights post-market authorisation issues, such as Risk Management Plans and substitution of products, and outlines some other issues, such as cost management and international nomenclature. This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products within the European context.

Biological Drug Products

Author : Wei Wang
Publisher : John Wiley & Sons
ISBN 13 : 1118695224
Total Pages : 531 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis Biological Drug Products by : Wei Wang

Download or read book Biological Drug Products written by Wei Wang and published by John Wiley & Sons. This book was released on 2013-08-29 with total page 531 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.

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

Drug-Drug Interactions for Therapeutic Biologics

Author : Honghui Zhou
Publisher : John Wiley & Sons
ISBN 13 : 1118630211
Total Pages : 272 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis Drug-Drug Interactions for Therapeutic Biologics by : Honghui Zhou

Download or read book Drug-Drug Interactions for Therapeutic Biologics written by Honghui Zhou and published by John Wiley & Sons. This book was released on 2013-05-10 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Strategize, plan, and execute comprehensive drug-drug interaction assessments for therapeutic biologics Offering both theory and practical guidance, this book fully explores drug-drug interaction assessments for therapeutic biologics during the drug development process. It draws together and analyzes all the latest findings and practices in order to present our current understanding of the topic and point the way to new research. Case studies and examples, coupled with expert advice, enable readers to better understand the complex mechanisms of biologic drug-drug interactions. Drug-Drug Interactions for Therapeutic Biologics features contributions from leading international experts in all areas of therapeutic biologics drug development and drug-drug interactions. The authors' contributions reflect a thorough review and analysis of the literature as well as their own firsthand laboratory experience. Coverage includes such essential topics as: Drug-drug interaction risks in combination with small molecules and other biologics Pharmacokinetic and pharmacodynamic drug-drug interactions In vitro methods for drug-drug interaction assessment and prediction Risk-based strategies for evaluating biologic drug-drug interactions Strategies to minimize drug-drug interaction risk and mitigate toxic interactions Key regulations governing drug-drug interaction assessments for therapeutic biologics. Drug-Drug Interactions for Therapeutic Biologics is recommended for pharmaceutical and biotechnology scientists, clinical pharmacologists, medicinal chemists, and toxicologists. By enabling these readers to understand how therapeutic biologics may interact with other drugs, the book will help them develop safer, more effective therapeutic biologics.

Immune Aspects of Biopharmaceuticals and Nanomedicines

Author : Raj Bawa
Publisher : CRC Press
ISBN 13 : 1351399780
Total Pages : 44 pages
Book Rating : 4.3/5 (513 download)

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Book Synopsis Immune Aspects of Biopharmaceuticals and Nanomedicines by : Raj Bawa

Download or read book Immune Aspects of Biopharmaceuticals and Nanomedicines written by Raj Bawa and published by CRC Press. This book was released on 2019-01-10 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt: The enormous advances in the immunologic aspects of biotherapeutics and nanomedicines in the past two decades has necessitated an authoritative and comprehensive reference source that can be relied upon by immunologists, biomedical researchers, clinicians, pharmaceutical companies, regulators, venture capitalists, and policy makers alike. This text provides a thorough understanding of immunology, therapeutic potential, clinical applications, adverse reactions, and approaches to overcoming immunotoxicity of biotherapeutics and nanomedicines. It also tackles critical, yet often overlooked topics such as immune aspects of nano-bio interactions, current FDA regulatory guidances, complement activation-related pseudoallergy (CARPA), advances in nanovaccines, and immunogenicity testing of protein therapeutics.