Perspectives on exploring hybrid LBA/LC-MS approach for clinical immunogenicity testing.
Bioanalysis
; 11(17): 1605-1617, 2019 Sep.
Article
em En
| MEDLINE
| ID: mdl-31208198
ABSTRACT
Biological drug products may elicit an antidrug antibody (ADA) response. The current widely used bridging ligand binding assay (LBA) is the gold standard for ADA assessments in drug development, which is a qualitative assay followed by a quasi-quantitative titer analysis but can be prone to interferences from biological matrices, drug targets and circulating drugs. We present our perspectives and findings in exploring a hybrid LBA/LC-MS as an orthogonal bioanalytical tool for clinical immunogenicity assessments. The hybrid LBA/LC-MS is a semiquantitative assay with acceptable specificity, drug tolerance and the capability of multiplexed detection of ADA isotypes. The assay results suggest this technology to be a promising and complementary bioanalytical tool that can provide informative immunogenicity data in drug development.
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Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Espectrometria de Massas
/
Técnicas Imunológicas
Tipo de estudo:
Qualitative_research
Limite:
Humans
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article