A bridging immunogenicity assay for anti-cabiralizumab antibodies: overcoming the low assay cut point and drug tolerance challenges.
Bioanalysis
; 13(5): 395-407, 2021 Mar.
Article
en En
| MEDLINE
| ID: mdl-33661021
ABSTRACT
Background:
To support the clinical studies of cabiralizumab, an immunogenicity assay for detecting anti-cabiralizumab antibodies is required.Results:
Strategies were developed to overcome two major bioanalytical challenges poor drug tolerance of the anti-drug antibodies assay and very low cut point observed in the screening and confirmatory assays. By using acid dissociation (400 mM glycine solution at pH 2.0), drug tolerance of 200 µg/ml drug was achieved for both the screening and confirmatory assays. Effects of biological matrix (disease state vs normal serum) and assay conditions (capture/detector reagent concentration, minimum required dilution, acid pretreatment) on assay cut points were systematically evaluated.Conclusion:
A bridging immunogenicity assay for detecting anti-cabiralizumab antibodies in human serum has been successfully developed, validated and applied to clinical studies.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Bioensayo
/
Anticuerpos Monoclonales Humanizados
Límite:
Humans
Idioma:
En
Revista:
Bioanalysis
Año:
2021
Tipo del documento:
Article
País de afiliación:
Estados Unidos