Detection and quantification of antibodies to biopharmaceuticals practical and applied considerations /

Detection and quantification of antibodies to biopharmaceuticals practical and applied considerations /

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Bibliographic Details
Corporate Author: ebrary, Inc
Other Authors: Tovey, Michael G.
Format: Electronic eBook
Language:English
Published: Hoboken, N.J. : Wiley, c2011.
Subjects:
Immunoglobulins > Analysis.
Immunoassay.
Electronic books.
Online Access:An electronic book accessible through the World Wide Web; click to view
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Table of Contents:
  • Principals of risk assessment and monitoring of antibody responses to biopharmaceuticals / Eugen Koren, Erik Foehr, and Charles A. O'Neill
  • Immunogenicity of therapeutic proteins : a regulatory perspective / Susan Kirshner
  • Guidance on immunogenicity assessment of biologically-derived therapeutic proteins : an European perspective / Meenu Wadhwa and Robin Thorpe
  • Japanese regulatory perspective on immunogenicity / Takao Hayakawa and Akiko Ishii
  • Enzyme immunoassays and radioimmune assays for quantification of anti-TNF biopharmaceuticals and anti-drug antibodies / Klaus Bendtzen and Morten Svenson
  • Confirmatory immunogenicity assays / Eric Wakshull and Daniel Coleman
  • The use of pharmacodynamics as a surrogate marker for the detection of anti-drug neutralizing antibodies / Florian Deisenhammer
  • Cell-based assays for the detection of neutralizing antibodies to interferon beta (IFN-?) and tumor necrosis factor-alpha (TNF-?) inhibitors / Anthony Meager
  • Detection of neutralizing antibodies (NABs) to Interferon-beta by real time RT-PCR / Francesca Gilli and Antonio Bertolotto
  • Competitive ligand binding assays for the detection of neutralizing antibodies / Bonnie Wu, George R. Gunn III, and Gopi Shankar
  • The use of surface plasmon resonance for the detection and characterization of antibodies / Steven J. Swanson and Daniel Mytych
  • Hypersensitivity reactions to biopharmaceuticals : detection and quantification of drug-specific IgE antibodies / Jørgen Dahlstrøm and Lennart Venemalm
  • Standardization and validation of immunoassays and biophysical assays for the detection of anti-drug antibodies / Daniel Kramer
  • Standardization and validation of cell-based assays for the detection of neutralizing anti-drug antibodies / Deborah Finco-Kent and Amy Grenham
  • Standardization of neutralizing antibody unitge by bioassay design : constant antigen and constant antibody methodology / Sidney E. Grossberg, Yoshimi Kawade, and Leslie D. Grossberg
  • Cut-points and performance characteristics for anti-drug antibody assays / Viswanath Devanarayan and Michael G. Tovey
  • Dilutional linearity for neutralizing antibody assays / David Lansky and Carrie Wager
  • Detection of neutralizing antibodies to biopharmaceuticals in the presence of high levels of circulating drug / Arno Kromminga and Michael G. Tovey.

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