Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics

The administration of biological therapeutics can evoke some level of immune response to the drug product in the receiving subjects. An immune response comprised of neutralizing antibodies can lead to loss of efficacy or potentially more serious clinical sequelae. Therefore, it is important to monit...

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Bibliographic Details
Published in:Journal of immunological methods 2007-04, Vol.321 (1), p.1-18
Main Authors: Gupta, Shalini, Indelicato, Stephen R., Jethwa, Vijay, Kawabata, Thomas, Kelley, Marian, Mire-Sluis, Anthony R., Richards, Susan M., Rup, Bonita, Shores, Elizabeth, Swanson, Steven J., Wakshull, Eric
Format: Article
Language:English
Subjects:
Animals
Antibodies - analysis
Antibodies - immunology
Biological and medical sciences
Biological Assay - methods
Biological Assay - standards
Biological Products - immunology
Biological Products - therapeutic use
Calibration
Cell Line
Cell-based assay
Fundamental and applied biological sciences. Psychology
Fundamental immunology
Guidelines as Topic
Humans
Immunoassay - methods
Immunoassay - standards
Immunogenicity assay
Molecular immunology
NAb assay
Neutralization Tests - methods
Neutralizing antibody bioassay
Reference Standards
Reproducibility of Results
Research Design
Sensitivity and Specificity
Serum-based bioassay
Techniques
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Summary:The administration of biological therapeutics can evoke some level of immune response to the drug product in the receiving subjects. An immune response comprised of neutralizing antibodies can lead to loss of efficacy or potentially more serious clinical sequelae. Therefore, it is important to monitor the immunogenicity of biological therapeutics throughout the drug product development cycle. Immunoassays are typically used to screen for the presence and development of anti-drug product antibodies. However, in-vitro cell-based assays prove extremely useful for the characterization of immunoassay-positive samples to determine if the detected antibodies have neutralizing properties. This document provides scientific recommendations based on the experience of the authors for the development of cell-based assays for the detection of neutralizing antibodies in non-clinical and clinical studies.
ISSN:0022-1759
1872-7905
DOI:10.1016/j.jim.2006.12.004