PK assays for antibody-drug conjugates: case study with ado-trastuzumab emtansine.
Bioanalysis
; 5(9): 1025-40, 2013 May.
Article
em En
| MEDLINE
| ID: mdl-23641694
ABSTRACT
BACKGROUND:
Antibody-drug conjugates (ADCs) combine the characteristics of large-molecule biologics and small-molecule drugs and are heterogeneous mixtures that can biotransform in vivo, resulting in additional complexity. ADC bioanalytical strategies require novel analytical methods, as well as existing large- and small-molecule methods. Because ADCs in late-stage clinical development are relatively new, regulatory guidelines and standard industry best practices for developing strategies for bioanalytical PK assays are still being established.RESULTS:
A PK assay strategy was developed that included comprehensive novel reagent and assay characterization approaches for the ADC ado-trastuzumab emtansine (T-DM1).CONCLUSION:
The bioanalytical strategy was successfully applied to the drug development of T-DM1 and ensured that key analytes were accurately measured in support of nonclinical and clinical development.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Ensaio de Imunoadsorção Enzimática
/
Imunoconjugados
/
Anticorpos Monoclonais Humanizados
/
Maitansina
/
Anticorpos Monoclonais
Tipo de estudo:
Guideline
/
Prognostic_studies
Idioma:
En
Revista:
Bioanalysis
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Estados Unidos