Detection and Quantification of Antibodies to

Providing a comprehensive review of neutralization and the ability to measure and apply antibodies to modern science and medicine, Detection and Quantification of Antibodies to Biopharmaceuticals: Practical and Applied Considerations provides biotechnology companies and pharma drug development specialists with insight into the design, optimization, and qualification of assays, as well as the establishment of sampling strategies, choice of appropriate assay end-points, and data analysis for the detection and quantification of neutralizing antibodies to biopharmaceuticals. The text also compares the strengths and weaknesses of various assays.

Michael G.Tovey, PhD, Inserm Director of Research in the Laboratory of Biotechnology and Applied Pharmacology, Ecole Normale Superieure de Cachan, France. He is an Associate Editor of the Journal of interferon and Cytokine Research and author of more than two hundred articles on interferon, cytokines, and biotechnology.

Introduction; A Perspective	p. ix
Contributors	p. xxi
Risk-Based Strategies	p. 1
Principles of Risk Assessment and Monitoring of Antibody Responses to Biopharmaceuticals	p. 3
Regulatory Requirements	p. 13
Immunogenicity of Therapeutic Proteins: A Regulatory Perspective	p. 15
Guidance on Immunogenicity Assessment of Biologically Derived Therapeutic Proteins: A European Perspective	p. 37
Japanese Regulatory Perspective on Immunogenicity	p. 57
Principal Technologies Employed For The Quantification Of Anti-Drug Antibodies	p. 81
Enzyme Immunoassays and Radioimmunoassays for Quantification of Anti-TNF Biopharmaceuticals and Anti-Drug Antibodies	p. 83
Confirmatory Immunogenicity Assays	p. 103
The Use of Pharmacodynamics as a Surrogate Marker for the Detection of Anti-Drug Neutralizing Antibodies	p. 119
Cell-Based Assays for the Detection of Neutralizing Antibodies to Interferon Beta (IFN-ß) and Tumor Necrosis Factor Alpha (TNF-a) Inhibitors	p. 133
Detection of Neutralizing Antibodies against Interferon Beta by Real-Time RT-PCR	p. 157
Competitive Ligand-Binding Assays for the Detection of Neutralizing Antibodies	p. 175
The Use of Surface Plasmon Resonance for the Detection and Characterization of Antibodies	p. 193
Hypersensitivity Reactions to Biopharmaceuticals: Detection and Quantificationjof Drug-Specific IgE Antibodies	p. 211
Assay Standardization And Validation	p. 233
Standardization and Validation of Immunoassays	p. 235
Standardization and Validation of Cell-Based Assays for the Detection of Neutralizing Anti-Drug Antibodies	p. 243
Standardization of Neutralizing Antibody Unitage by Bioassay Design: Constant Antigen and Constant Antibody Methodology	p. 269
Statistical Considerations	p. 287
Cut Points and Performance Characteristics for Anti-Drug Antibody Assays	p. 289
Dilutional Linearity for Neutralizing Antibody Assays	p. 309
Adaptation Of Anti-Drug Antibody Assays To Challenging Conditions	p. 319
Detection of Antibodies to Biopharmaceuticals in the Presence of High Levels of Circulating Drug	p. 321
Antibody Assays in Animal Research	p. 331
Immunogenicity of Microbial Digestive Enzymes for Oral Replacement Therapy in Pancreatic Exocrine Insufficiency	p. 343
Novel Technologies For The Quantification Of Neutralizing Antibodies	p. 369
Measurement of Biologically Active Drug as an Approach to Detection of Anti-Drug Neutralizing Antibodies	p. 371
A Novel One-Step Cell-Based Assay for Quantification of Neutralizing Antibodies to Biopharmaceuticals	p. 383
Index	p. 399
Table of Contents provided by Ingram. All Rights Reserved.

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Detection and Quantification of Antibodies to Biopharmaceuticals Practical and Applied Considerations

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