Toward best practices in data processing and analysis for intact biotherapeutics by MS in quantitative bioanalysis.
Bioanalysis
; 9(23): 1883-1893, 2017 Dec.
Article
en En
| MEDLINE
| ID: mdl-29171758
ABSTRACT
AIM:
Typically, quantitation of biotherapeutics from biological matrices by LC-MS is based on a surrogate peptide approach to determine molecule concentration. Recent efforts have focused on quantitation of the intact protein molecules or larger mass subunits of monoclonal antibodies. To date, there has been limited guidance for large or intact protein mass quantitation for quantitative bioanalysis.METHODOLOGY:
Intact- and subunit-level analyses of biotherapeutics from biological matrices are performed at 12-25 kDa mass range with quantitation data presented.RESULTS:
Linearity, bias and other metrics are presented along with recommendations made on the viability of existing quantitation approaches.CONCLUSION:
This communication is intended to start a discussion around intact protein data analysis and processing, recognizing that other published contributions will be required.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Espectrometría de Masas en Tándem
/
Anticuerpos Monoclonales
Tipo de estudio:
Guideline
Límite:
Animals
Idioma:
En
Revista:
Bioanalysis
Año:
2017
Tipo del documento:
Article
País de afiliación:
Estados Unidos