Detection and Quantification of Antibodies to Biopharmaceuticals Practical and Applied Considerations 1st Edition by Michael Tovey ISBN 047110793X 978-0471107934

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Product details: 

ISBN 10:  047110793X 

ISBN 13: 978-0471107934

Author: Michael G. Tovey

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.

Table of contents: 

1. Introduction: A Perspective
2. Principles of Risk Assessment and Monitoring of Antibody Responses to Biopharmaceuticals
3. Immunogenicity of Therapeutic Proteins: A Regulatory Perspective
4. Guidance on Immunogenicity Assessment of Biologically Derived Therapeutic Proteins: A European Perspective
5. Japanese Regulatory Perspective on Immunogenicity
6. Enzyme Immunoassays and Radioimmunoassays for Quantification of Anti-TNF Biopharmaceuticals and Anti-Drug Antibodies
7. Confirmatory Immunogenicity Assays
8. The Use of Pharmacodynamics as a Surrogate Marker for the Detection of Anti-Drug Neutralizing Antibodies
9. Cell-Based Assays for the Detection of Neutralizing Antibodies to Interferon Beta (IFN-β) and Tumor Necrosis Factor Alpha (TNF-α) Inhibitors
10. Detection of Neutralizing Antibodies against Interferon Beta by Real-Time RT-PCR
11. Competitive Ligand-Binding Assays for the Detection of Neutralizing Antibodies
12. The Use of Surface Plasmon Resonance for the Detection and Characterization of Antibodies
13. Hypersensitivity Reactions to Biopharmaceuticals: Detection and Quantification of Drug-Specific IgE Antibodies
14. Standardization and Validation of Immunoassays
15. Standardization and Validation of Cell-Based Assays for the Detection of Neutralizing Anti-Drug Antibodies
16. Standardization of Neutralizing Antibody Unitage by Bioassay Design: Constant Antigen and Constant Antibody Methodology
17. Cut Points and Performance Characteristics for Anti-Drug Antibody Assays
18. Dilutional Linearity for Neutralizing Antibody Assays
19. Detection of Antibodies to Biopharmaceuticals in the Presence of High Levels of Circulating Drug
20. Antibody Assays in Animal Research
21. Immunogenicity of Microbial Digestive Enzymes for Oral Replacement Therapy in Pancreatic Exocrine Insufficiency
22. Measurement of Biologically Active Drug as an Approach to Detection of Anti-Drug Neutralizing Antibodies
23. A Novel One-Step Cell-Based Assay for Quantification of Neutralizing Antibodies to Biopharmaceuticals

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Tags: Michael Tovey, Detection and Quantification, Antibodies to Biopharmaceuticals