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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.

Still the most comprehensive reference source on the development, production and therapeutic application of antibodies, this second edition is thoroughly updated and now has 30% more content. Volume 1 covers selection and engineering strategies for new antibodies, while the second volume presents novel therapeutic concepts and antibodies in clinical study, as well as their potential. Volumes 3 and 4 feature detailed and specific information about each antibody approved for therapeutic purposes, including clinical data. This unique handbook concludes with a compendium of marketed monoclonal antibodies and an extensive index. Beyond providing current knowledge, the authors discuss emerging technologies, future developments, and intellectual property issues, such that this handbook meets the needs of academic researchers, decision makers in industry and healthcare professionals in the clinic.

The Novartis Foundation Series is a popular collection of the proceedings from Novartis Foundation Symposia, in which groups of leading scientists from a range of topics across biology, chemistry and medicine assembled to present papers and discuss results. The Novartis Foundation, originally known as the Ciba Foundation, is well known to scientists and clinicians around the world.

This is the first book to address all aspects of the biology of autoantibodies in a single volume, including a discussion of immunology, experimental models, clinical aspects, and the use of autoantibodies as probes in molecular and cellular biology. The editor, currently professor at the W.M. Keck Autoimmune Disease Center of The Scripps Research Institute, has assembled an all-star team of authors to report on the latest research, technologies, and applications. Following an introductory chapter, the book goes on to cover such topics as cellular mechanisms of autoantibody production, clinical and diagnostic usefulness in human disease, and animal models used to study the elicitation of autoantibodies. The whole is rounded off with a look at future perspectives. With its comprehensive coverage, this volume will appeal not only to immunologists and clinicians but also to cell and molecular biologists.

Traditional column chromatography dominates current purification technology, and many of the productivity gains that have been achieved have relied on upscaling such devices. However, this comes with a cost penalty and the pharmaceutical industry has reached the point at which further upscaling becomes economically unsupportable. This book offers a broad-based reassessment of old and new purification methods, incorporating an analysis of innovative new trends in purification. The book has wide coverage of different antibody purification strategies and brings together top-tier experts to address problems in process-scale antibody purification.