Recommendations for the development and validation of confirmatory anti-drug antibody assays.
Bioanalysis
; 7(13): 1619-31, 2015.
Article
en En
| MEDLINE
| ID: mdl-26226311
ABSTRACT
Identification and characterization of anti-drug antibodies is a critical component of biopharmaceutical drug development. The tiered approach for immunogenicity testing consists of screening, confirmatory, and characterization assays. Herein, we provide recommendations for confirmatory assays by expanding upon published guidance and present common practices across the industry. The authors recommend scientific approaches for development and validation of confirmatory assays using competition methods in ligand-binding assays, along with statistical formulae for routine use and validation. The paper will assist in understanding the confirmatory assay, and carefully implementing validation criteria a priori, as well as during sample analysis. These approaches represent the authors' current knowledge and practices, with the aim that more uniform practices will be applied across the industry.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Bioensayo
/
Anticuerpos Monoclonales
Tipo de estudio:
Guideline
/
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
Bioanalysis
Año:
2015
Tipo del documento:
Article
País de afiliación:
Estados Unidos