Detection and quantification of antibodies to biopharmaceuticals
Subtitle: practical and applied considerations
By: [edited] by Michael G. Tovey
Publisher: Wiley
Published: 2011
Place of publication: Hoboken, N.J
Language: eng
Number of pages: 404
ISBN-13: 9780470566664
Subjects: Immunoassay; Biological Products; Immunology; Methods; Immunoglobulins; Analysis; Neutralizing Antibodies
Notes: Includes bibliographical references.
Table of contents: title: Principals of risk assessment and monitoring of antibody responses to biopharmaceuticals / Eugen Koren, Erik Foehr, and Charles A. O'Neill; title: Immunogenicity of therapeutic proteins : a regulatory perspective / Susan Kirshner; title: Guidance on immunogenicity assessment of biologically-derived therapeutic proteins : an European perspective / Meenu Wadhwa and Robin Thorpe; title: Japanese regulatory perspective on immunogenicity / Takao Hayakawa and Akiko Ishii; title: Enzyme immunoassays and radioimmune assays for quantification of anti-TNF biopharmaceuticals and anti-drug antibodies / Klaus Bendtzen and Morten Svenson; title: Confirmatory immunogenicity assays / Eric Wakshull and Daniel Coleman; title: The use of pharmacodynamics as a surrogate marker for the detection of anti-drug neutralizing antibodies / Florian Deisenhammer; title: Cell-based assays for the detection of neutralizing antibodies to interferon beta (IFN-?) and tumor necrosis factor-alpha (TNF-?) inhibitors / Anthony Meager; title: Detection of neutralizing antibodies (NABs) to Interferon-beta by real time RT-PCR / Francesca Gilli and Antonio Bertolotto; title: Competitive ligand binding assays for the detection of neutralizing antibodies / Bonnie Wu, George R. Gunn III, and Gopi Shankar; title: The use of surface plasmon resonance for the detection and characterization of antibodies / Steven J. Swanson and Daniel Mytych; title: Hypersensitivity reactions to biopharmaceuticals : detection and quantification of drug-specific IgE antibodies / Jørgen Dahlstrøm and Lennart Venemalm; title: Standardization and validation of immunoassays and biophysical assays for the detection of anti-drug antibodies / Daniel Kramer; title: Standardization and validation of cell-based assays for the detection of neutralizing anti-drug antibodies / Deborah Finco-Kent and Amy Grenham; title: Standardization of neutralizing antibody unitge by bioassay design : constant antigen and constant antibody methodology / Sidney E. Grossberg, Yoshimi Kawade, and Leslie D. Grossberg; title: Cut-points and performance characteristics for anti-drug antibody assays / Viswanath Devanarayan and Michael G. Tovey; title: Dilutional linearity for neutralizing antibody assays / David Lansky and Carrie Wager; title: Detection of neutralizing antibodies to biopharmaceuticals in the presence of high levels of circulating drug / Arno Kromminga and Michael G. Tovey.