Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics.
J Immunol Methods
; 321(1-2): 1-18, 2007 Apr 10.
Article
en En
| MEDLINE
| ID: mdl-17307199
ABSTRACT
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.
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Banco de datos:
MEDLINE
Asunto principal:
Bioensayo
/
Productos Biológicos
/
Inmunoensayo
/
Anticuerpos
Tipo de estudio:
Diagnostic_studies
/
Guideline
Límite:
Animals
/
Humans
Idioma:
En
Revista:
J Immunol Methods
Año:
2007
Tipo del documento:
Article
País de afiliación:
Estados Unidos