Viral Vectors in Gene Therapies: Review of International Regulatory Strategies for Risk Management
DOI:
https://doi.org/10.62035/rca.7.88Keywords:
Terapia Genética, Medición de Riesgo, Farmacovigilancia, Legislación de Medicamentos, Vectores GenéticosAbstract
Gene therapies based on viral vectors represent one of the most advanced strategies in personalized medicine. However, their use entails significant risks, including immunogenicity, insertional mutagenesis, genotoxicity, and the presence of replication-competent viruses. This literature review critically analyzes the main international regulatory approaches—FDA, EMA, and ICH—regarding the safety evaluation of viral vectors used in gene therapy products. It classifies the types of vectors employed, describes the identified risk mechanisms, and reviews the principal analytical tools used for their control, such as integration assays, immunotoxicity assessments, biodistribution studies, and replication-competent virus detection. In addition, it discusses the regulatory criteria applied internationally, highlighting recent advances and persistent limitations, especially in contexts where regulatory frameworks are still under development. This review aims to contribute to a better understanding of the technical and scientific requirements needed to ensure the safety of these biotechnological products.
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