{"product_id":"detection-and-quantification-of-antibodies-to-biopharmaceuticals-practical-and-applied-considerations-hardback-9780470566664","title":"Detection and Quantification of Antibodies to Biopharmaceuticals; Practical and Applied Considerations (Hardback) 9780470566664","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eDetection and Quantification of Antibodies to Biopharmaceuticals\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003ePractical and Applied Considerations\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eMichael G. Tovey (Edited by), MG Tovey (Author)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780470566664, Wiley\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 2 September 2011\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e458 pages\u003cbr\u003e23.4 x 15.8 x 2.8 cm, 0.794 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003cp\u003eThe definitive book on the neutralization of recombinant biopharmaceuticals\u003c\/p\u003e \u003cp\u003eRecombinant 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.\u003c\/p\u003e \u003cp\u003eThe 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.\u003c\/p\u003e \u003cp\u003eBringing 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.\u003c\/p\u003e \u003cp\u003eDesigned 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.\u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cb\u003eINTRODUCTION\u003ci\u003e:\u003c\/i\u003e A PERSPECTIVE ix\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eMichael G. Tovey\u003c\/i\u003e  \u003cp\u003e\u003cb\u003eCONTRIBUTORS xxi\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePART I RISK-BASED STRATEGIES 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Principles of Risk Assessment and Monitoring of Antibody Responses to Biopharmaceuticals 3\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eEugen Koren, Erik Foehr, and Charles A. O’Neill\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePART II REGULATORY REQUIREMENTS 13\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Immunogenicity of Therapeutic Proteins: A Regulatory Perspective 15\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSusan Kirshner\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Guidance on Immunogenicity Assessment of Biologically Derived Therapeutic Proteins: A European Perspective 37\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eMeenu Wadhwa and Robin Thorpe\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Japanese Regulatory Perspective on Immunogenicity 57\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eTakao Hayakawa and Akiko Ishii-Watabe\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePART III PRINCIPAL TECHNOLOGIES EMPLOYED FOR THE QUANTIFICATION OF ANTI-DRUG ANTIBODIES 81\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Enzyme Immunoassays and Radioimmunoassays for Quantification of Anti-TNF Biopharmaceuticals and Anti-Drug Antibodies 83\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eKlaus Bendtzen and Morten Svenson\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Confirmatory Immunogenicity Assays 103\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eEric Wakshull and Daniel Coleman\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 The Use of Pharmacodynamics as a Surrogate Marker for the Detection of Anti-Drug Neutralizing Antibodies 119\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eFlorian Deisenhammer\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Cell-Based Assays for the Detection of Neutralizing Antibodies to Interferon Beta (IFN-β) and Tumor Necrosis Factor Alpha (TNF-α) Inhibitors 133\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eAnthony Meager\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Detection of Neutralizing Antibodies against Interferon Beta by Real-Time RT-PCR 157\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eFrancesca Gilli and Antonio Bertolotto\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Competitive Ligand-Binding Assays for the Detection of Neutralizing Antibodies 175\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eBonnie W. Wu, George R. Gunn III, and Gopi Shankar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 The Use of Surface Plasmon Resonance for the Detection and Characterization of Antibodies 193\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSteven J. Swanson and Daniel Mytych\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Hypersensitivity Reactions to Biopharmaceuticals: Detection and Quantification of Drug-Specific IgE Antibodies 211\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eJörgen Dahlström and Lennart Venemalm\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePART IV ASSAY STANDARDIZATION AND VALIDATION 233\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Standardization and Validation of Immunoassays 235\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eDaniel Kramer\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Standardization and Validation of Cell-Based Assays for the Detection of Neutralizing Anti-Drug Antibodies 243\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eDeborah Finco-Kent and Amy Grenham\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Standardization of Neutralizing Antibody Unitage by Bioassay Design: Constant Antigen and Constant Antibody Methodology 269\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSidney E. Grossberg, Yoshimi Kawade, and Leslie D. Grossberg\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePART V STATISTICAL CONSIDERATIONS 287\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 Cut Points and Performance Characteristics for Anti-Drug Antibody Assays 289\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eViswanath Devanarayan and Michael G. Tovey\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 Dilutional Linearity for Neutralizing Antibody Assays 309\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eDavid Lansky and Carrie Wager\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePART VI ADAPTATION OF ANTI-DRUG ANTIBODY ASSAYS TO CHALLENGING CONDITIONS 319\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e18 Detection of Antibodies to Biopharmaceuticals in the Presence of High Levels of Circulating Drug 321\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eArno Kromminga and Michael G. Tovey\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e19 Antibody Assays in Animal Research 331\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eVera Brinks, Francesca Gilli, Melody Sauerborn, and Huub Schellekens\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e20 Immunogenicity of Microbial Digestive Enzymes for Oral Replacement Therapy in Pancreatic Exocrine Insufficiency 343\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eClaudia Berger and Uwe Niesner\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePART VII NOVEL TECHNOLOGIES FOR THE QUANTIFICATION OF NEUTRALIZING ANTIBODIES 369\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e21 Measurement of Biologically Active Drug as an Approach to Detection of Anti-Drug Neutralizing Antibodies 371\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eYao Zhuang and Shalini Gupta\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e22 A Novel One-Step Cell-Based Assay for Quantification of Neutralizing Antibodies to Biopharmaceuticals 383\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eChristophe Lallemand and Michael G. Tovey\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eINDEX 399\u003c\/b\u003e\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Chemistry [\u003ca title=\"See our other books on Chemistry\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Chemistry%20%5BPN%5D%22\"\u003ePN\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Wiley","offers":[{"title":"Brand New","offer_id":52276364247320,"sku":"9780470566664","price":105.99,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/files\/9780470566664.jpg?v=1781367453","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/detection-and-quantification-of-antibodies-to-biopharmaceuticals-practical-and-applied-considerations-hardback-9780470566664","provider":"Freshly Printed Books","version":"1.0","type":"link"}