Detection And Quantification Of Antibodies To Biopharmaceuticals: Practical And Applied Considerations
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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.
目次
Section I – Risk-Based Strategies.
Chapter 1. Principles of Risk Assessment and Monitoring of Antibody Responses to Biopharmaceuticals (Eugen Koren, Erik Foehr, and Charles A. O’Neill).
Section II – Regulatory Requirements.
Chapter 2. Immunogenicity of Therapeutic Proteins: A Regulatory Perspective (Susan Kirshner).
Chapter 3. Guidance on Immunogenicity Assessment of Biologically-Derived Therapeutic Proteins: An European Perspective (Meenu Wadhwa and Robin Thorpe).
Chapter 4. Japanese Regulatory Perspective on Immunogenicity (Takao Hayakawa and Akiko Ishii).
Section III – Principal Technologies Employed for the Quantification of Anti-Drug Antibodies.
Chapter 5. Enzyme Immunoassays and Radioimmune Assays for Quantification of Anti-TNF Biopharmaceuticals and Anti-Drug Antibodies (Klaus Bendtzen and Morten Svenson).
Chapter 6. Confirmatory Immunogenicity Assays (Eric Wakshull and Daniel Coleman).
Chapter 7. The Use of Pharmacodynamics as a Surrogate Marker for the Detection of Anti-Drug Neutralizing Antibodies (Florian Deisenhammer).
Chapter 8. Cell-based assays for the Detection of Neutralizing Antibodies to Interferon beta (IFN-ß) and Tumor Necrosis Factor-alpha (TNF-a) Inhibitors (Anthony Meager).
Chapter 9. Detection of Neutralizing Antibodies (NABs) to Interferon-Beta by Real Time RT-PCR (Francesca Gilli, and Antonio Bertolotto).
Chapter 10. Competitive Ligand Binding Assays for the Detection of Neutralizing Antibodies (Bonnie Wu, George R. Gunn, and Gopi Shankar).
Chapter 11. The Use of Surface Plasmon Resonance for the Detection and Characterization of Antibodies (Steven J. Swanson and Daniel Mytych).
Chapter 12. Hypersensitivity Reactions to Biopharmaceuticals: Detection and Quantification of drug-Specific IgE Antibodies (Jörgen Dahlström and Lennart Venemalm).
Section IV. Assay Standardization and Validation.
Chapter 13. Standardization and Validation of Immunoassays and Biophysical Assays for the Detection of Anti-drug Antibodies (Daniel Kramer).
Chapter 14. Standardization and Validation of Cell-Based Assays for the Detection of Neutralizing Anti-drug Antibodies (Deborah Finco-Kent and Amy Grenham).
Chapter 15. Standardization of Neutrializing Antodody Unitge by Bioassay Design: Constant Antigen and Constant Antibody Methodology (Sidney E. Grossberg, Yoshimi Kawade and Leslie D. Grossberg).
Section V. Statistical Considerations.
Chapter 16. Cut-Points and Performance Characteristics for Anti-Drug Antibody Assays (Viswanath Devanarayan and Michael G. Tovey).
Chapter 17. Dilutional Linearity for Neutralizing Antibody Assays (David Lansky and Carrie Wager).
Section VI. Adaptation of Neutralization Assays to Challenging Conditions.
Chapter 18. Detection of Neutralizing Antibodies to Biopharmaceuticals in the Presence of High Levels of Circulating Drug (Arno Kromminga and Michael G. Tovey).
Chapter 19. Antibody Assays in Animal Researc (Vera Brinks, Francesca Gilli, Melody Sauerborn, and Huub Schellekens).
Chapter 20. Immunogenicity of Microbial Digestive Enzymes for Oral Replacement Therapy in Pancreatic Exocrine Insufficiency (Claudia Berger and Uwe Niesner).
Section VII. Novel Technologies for the Quantification of Neutralizing Antibodies.
Chapter 21. Drug Quantification Based-Assay for Neutralizing Antibodies (Yao Zhuang and Shalini Gupta).
Chapter 22. A Novel O ne-Step Cell-Based Assay for the Quantification of Neutralizing Antibodies to Biopharmaceuticals (Christophe Lallemand and Michael G. Tovey).
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