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Productos biológicos subcutáneos de alta concentración: desafíos y avances
Guangli Hu1, Mikolaj Milewski1, Yogita Krishnamachari1
1Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, NJ 07065, United States.
Advanced drug delivery reviews
|February 8, 2026
Resumen
Las formulaciones biológicas subcutáneas (SC) de alta dosis ofrecen beneficios para el paciente pero presentan desafíos. Las innovaciones en formulación, dispositivos y análisis son cruciales para desarrollar biológicos SC eficaces.
Área de la Ciencia:
- Desarrollo biofarmacéutico
- Sistemas de administración de fármacos
Sus antecedentes:
- La administración subcutánea (SC) es preferida para los biológicos sobre la infusión intravenosa (IV) debido a la conveniencia, adherencia y costo.
- Existe una demanda creciente de formulaciones subcutáneas de alta dosis (HiSubQ) para fármacos de dosis grandes.
Objetivo del estudio:
- Revisar los avances en el desarrollo de fármacos SC, centrándose en la formulación, la biofarmacéutica, los dispositivos y el análisis.
- Proponer estrategias para el desarrollo de soluciones biológicas SC centradas en el paciente.
Principales métodos:
- Revisión de la literatura actual sobre formulación de biológicos SC, fabricación, desarrollo de dispositivos y caracterización analítica.
- Identificación de desafíos y soluciones innovadoras en el desarrollo de HiSubQ.
Principales resultados:
- La administración SC ofrece ventajas sobre la infusión IV.
- El desarrollo de HiSubQ enfrenta obstáculos como la inestabilidad de las proteínas y la alta viscosidad.
- Las innovaciones en ingeniería de proteínas, formulación, dispositivos y análisis son clave.
Conclusiones:
- La colaboración interdisciplinaria es esencial para la innovación en biológicos SC.
- Las tácticas y hojas de ruta pueden guiar el desarrollo de biológicos SC centrados en el paciente para satisfacer la demanda del mercado.
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