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Métodos Multi-Atributo en la Caracterización y Control de Calidad de Conjugados Anticuerpo-Fármaco: Oportunidades,

Devendra Kumar¹, Neerja Trivedi²

¹Department of Pediatrics, Hematology/Oncology Division, University of Nebraska Medical Center, Omaha, NE, USA.

Journal of chromatography. A

|January 22, 2026

Resumen

Los Métodos de Múltiples Atributos (MAM) que utilizan espectrometría de masas ofrecen una caracterización avanzada para conjugados anticuerpo-fármaco (ADC). Estos métodos proporcionan un control de calidad sensible y específico para biofármacos complejos, abordando los desafíos en el desarrollo de ADC.

Área de la Ciencia:

Desarrollo Biofarmacéutico
Química Analítica
Espectrometría de Masas

Sus antecedentes:

Los conjugados anticuerpo-fármaco (ADC) son biofármacos complejos con heterogeneidad estructural inherente.
Esta heterogeneidad plantea desafíos significativos para la caracterización y el control de calidad durante el desarrollo de ADC.

Objetivo del estudio:

Revisar los avances recientes en la aplicación de Métodos de Múltiples Atributos (MAM) al desarrollo de conjugados anticuerpo-fármaco (ADC).
Destacar el papel del MAM en el monitoreo de atributos críticos de calidad y en la abordaje de los desafíos en la caracterización de ADC.

Principales métodos:

Utilización de Métodos de Múltiples Atributos (MAM) basados en espectrometría de masas de alta resolución.
Análisis de ADC a nivel de proteína intacta, subunidades y péptidos.
Comparación del MAM con técnicas analíticas tradicionales.

Principales resultados:

El MAM permite la identificación y cuantificación simultánea de atributos críticos de calidad en los ADC.
El MAM ofrece mayor especificidad, sensibilidad y detección de modificaciones inesperadas en comparación con los ensayos tradicionales.
Se destacan estrategias para monitorear la distribución de la relación fármaco-anticuerpo (DAR), la ocupación del sitio de conjugación y la estabilidad del enlazador/carga útil utilizando MAM.

Conclusiones:

El MAM es una plataforma potente y versátil para la caracterización y el control de calidad de ADC.
Abordar los desafíos en la calificación de métodos, el manejo de datos y la aceptación regulatoria es crucial para la implementación del MAM.
La automatización y el aprendizaje automático pueden mejorar la aplicación a gran escala del MAM para ADC, apoyando las presentaciones regulatorias y las pruebas de liberación.

Palabras clave:

conjugados anticuerpo-fármaco atributos críticos de calidad relación fármaco-anticuerpo EMA FDA método de múltiples atributos

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