Vectores virales en terapias génicas: revisión de estrategias regulatorias internacionales para la gestión de riesgos
DOI:
https://doi.org/10.62035/rca.7.88Palabras clave:
Terapia Genética, Medición de Riesgo, Farmacovigilancia, Legislación de Medicamentos, Vectores GenéticosResumen
Las terapias génicas basadas en vectores virales representan una de las estrategias más avanzadas en medicina personalizada. Sin embargo, su uso conlleva riesgos significativos, entre ellos inmunogenicidad, mutagénesis insercional, genotoxicidad y la presencia de virus replicantes. Esta revisión bibliográfica analiza críticamente los principales enfoques regulatorios internacionales —FDA, EMA e ICH— en relación con la evaluación de seguridad de los vectores virales utilizados en productos de terapia génica. Se clasifican los tipos de vectores empleados, se describen los mecanismos de riesgo identificados y se revisan las principales herramientas analíticas utilizadas para su control, como ensayos de integración, inmunotoxicidad, biodistribución y replicación competente. Además, se discuten los criterios regulatorios aplicables en el ámbito internacional, destacando los avances recientes y las limitaciones aún presentes, especialmente en contextos donde los marcos regulatorios están en consolidación. Esta revisión busca contribuir a la comprensión de las exigencias técnicas y científicas necesarias para garantizar la seguridad de estos productos biotecnológicos.
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Derechos de autor 2026 Agustín Martilotta
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