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Evaluación de la desarrollabilidad con cuatro formulaciones de vacunas ARNm-LNP comparando la inmunogenicidad en
Max Fairlamb1, Ozan S Kumru1, John M Hickey1
1Department of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, Lawrence, KS 66047, USA.
Journal of pharmaceutical sciences
|February 13, 2026
Resumen
Un nuevo flujo de trabajo estandariza las pruebas de estabilidad de las vacunas ARNm-LNP. Esta plataforma clasifica las formulaciones por estabilidad, identificando candidatos con mejores propiedades farmacéuticas para mejorar el desarrollo de vacunas.
Área de la Ciencia:
- Biotecnología
- Desarrollo de Vacunas
- Nanomedicina
Sus antecedentes:
- Los sistemas de administración de nanopartículas lipídicas (LNP) son cruciales para las vacunas de ARNm.
- La evaluación de la estabilidad de las formulaciones de ARNm-LNP es esencial para la eficacia de la vacuna y la vida útil.
Objetivo del estudio:
- Establecer un flujo de trabajo estandarizado para clasificar la estabilidad de la formulación de vacunas ARNm-LNP.
- Correlacionar los perfiles de estabilidad in vitro con mecanismos fisicoquímicos específicos y atributos estructurales.
Principales métodos:
- Evaluación comparativa de cuatro formulaciones de ARNm-LNP utilizando estudios de inmunogenicidad y estabilidad.
- Empleo de un conjunto de herramientas analíticas de rutina para evaluar la integridad química, estructural y funcional.
- Utilización de análisis de mapas de calor, microscopía electrónica criogénica (cryo-EM) y resonancia magnética nuclear de protón (RMN de ¹H) para la caracterización.
Principales resultados:
- Si bien la inmunogenicidad in vivo fue similar en todas las formulaciones, la estabilidad in vitro varió significativamente.
- La pérdida de funcionalidad se correlacionó con la degradación del ARNm (calor) y la disrupción de LNP (agitación, congelación-descongelación).
- Los atributos estructurales iniciales, como la formación de ampollas y la topología de la superficie lipídica, predijeron la estabilidad.
Conclusiones:
- Una plataforma de desarrollabilidad estandarizada ayuda a identificar candidatos a vacunas ARNm-LNP con propiedades farmacéuticas superiores.
- La comprensión de los mecanismos de estabilidad es clave para optimizar el diseño de vacunas ARNm-LNP.
- La caracterización estructural temprana puede predecir la estabilidad de la formulación.
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