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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.
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.
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.
This book gives pharmaceutical scientists an up-to-date resource on protein aggregation and its consequences, and available methods to control or slow down the aggregation process. While significant progress has been made in the past decade, the current understanding of protein aggregation and its consequences is still immature. Prevention or even moderate inhibition of protein aggregation has been mostly experimental. The knowledge in this book can greatly help pharmaceutical scientists in the development of therapeutic proteins, and also instigate further scientific investigations in this area. This book fills such a need by providing an overview on the causes, consequences, characterization, and control of the aggregation of therapeutic proteins.
Humans coexist with millions of harmless microorganisms, but emerging diseases, resistance to antibiotics, and the threat of bioterrorism are forcing scientists to look for new ways to confront the microbes that do pose a danger. This report identifies innovative approaches to the development of antimicrobial drugs and vaccines based on a greater understanding of how the human immune system interacts with both good and bad microbes. The report concludes that the development of a single superdrug to fight all infectious agents is unrealistic.
The Janeway's Immunobiology CD-ROM, Immunobiology Interactive, is included with each book, and can be purchased separately. It contains animations and videos with voiceover narration, as well as the figures from the text for presentation purposes.
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.
Wound repair is an important and growing sector of the medical industry with increasingly sophisticated biomaterials and strategies being developed to treat wounds. Advanced wound repair therapies provides readers with up-to-date information on current and emerging biomaterials and advanced therapies concerned with healing surgical and chronic wounds.Part one provides an introduction to chronic wounds, with chapters covering dysfunctional wound healing, scarring and scarless wound healing and monitoring of wounds. Part two covers biomaterial therapies for chronic wounds, including chapters on functional requirements of wound repair biomaterials, polymeric materials for wound dressings and interfacial phenomena in wound healing. In part three, molecular therapies for chronic wounds are discussed, with chapters on topics such as drug delivery, molecular and gene therapies and antimicrobial dressings. Part four focuses on biologically-derived and cell-based therapies for chronic wounds, including engineered tissues, biologically-derived scaffolds and stem cell therapies for wound repair. Finally, part five covers physical stimulation therapies for chronic wounds, including electrical stimulation, negative pressure therapy and mechanical debriding devices.With its distinguished editor and international team of contributors, Advanced wound repair therapies is an essential reference for researchers and materials scientists in the wound repair industry, as well as clinicians and those with an academic research interest in the subject. - Provides readers with up-to-date information on current and emerging biomaterials and advanced therapies concerned with healing surgical and chronic wounds - Chapters include the role of micro-organisms and biofilms in dysfunctional wound healing, tissue-biomaterial interaction and electrical stimulation for wound healing - Covers biologically-derived and cell-based therapies for chronic wounds, including engineered tissues, biologically-derived scaffolds and stem cell therapies for wound repair
Emphasizing the newest developments in the field, this volume presents detailed methodswith added emphasison therapeutic protein discovery. It features key tips and valuable implementation advice to ensure successful results."
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.