Comparison of assay formats used for the detection of pre-existing anti-drug antibodies against monoclonal antibodies.
Bioanalysis
; 14(13): 923-933, 2022 Jul.
Article
em En
| MEDLINE
| ID: mdl-36066084
ABSTRACT
Aim:
Assessment of pre-existing anti-drug antibody (preADA) reactivity at early drug development stages can be beneficial for candidate selection. We investigated the applicability of a generic immune-complex anti-drug antibody (ADA) assay for early preADA assessment as an easily available alternative to the commonly used ADA bridging assay.Results:
The results confirmed the expected assay difference regarding isotype detectability. Tested drug candidates were identified as preADA-reactive using the immune-complex ADA assay despite its limitation of not being able to detect IgM-type preADAs.Conclusion:
We recommend a purpose-driven use of the two assay formats. For the purpose of ranking different Pro329Gly mutation-bearing drug candidates, the immune-complex ADA assay is preferred in the phase before selecting a drug for clinical development.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Anticorpos Monoclonais
/
Complexo Antígeno-Anticorpo
Tipo de estudo:
Diagnostic_studies
Idioma:
En
Revista:
Bioanalysis
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Alemanha