Regulatory insights into nanomedicine and gene vaccine innovation: Safety assessment, challenges, and regulatory perspectives DOI Creative Commons
Eliana B. Souto, Cristina Blanco-Llamero, Karolline Krambeck

и другие.

Acta Biomaterialia, Год журнала: 2024, Номер 180, С. 1 - 17

Опубликована: Апрель 10, 2024

This analysis explores the principal regulatory concerns linked to nanomedicines and gene vaccines, including complexities involved perspectives on how navigate them. In realm of nanomedicines, ensuring safety nanomaterials is paramount due their unique characteristics potential interactions with biological systems. Regulatory bodies are actively formulating guidelines standards assess risks associated nanomedicine products, emphasizing need for standardized characterization techniques accurately gauge effectiveness. Regarding frameworks must be tailored address distinct challenges posed by genetic interventions, necessitating special considerations in efficacy evaluations, particularly concerning vector design, target specificity, long-term patient monitoring. Ethical such as autonomy, informed consent, privacy also demand careful attention, alongside intricate matter intellectual property rights, which balanced against imperative widespread access these life-saving treatments. Collaborative efforts among bodies, researchers, patent offices, private sector essential tackle effectively, international cooperation being especially crucial given global scope vaccine development. Striking right balance between safeguarding properties promoting public health vital fostering innovation equitable ground-breaking technologies, underscoring significance addressing hurdles fully harness benefits vaccines enhancing healthcare outcomes a scale. STATEMENT OF SIGNIFICANCE: Several biomaterials proposed development nanovaccines, from polymeric micelles, PLGA-/PEI-/PLL-nanoparticles, solid lipid nananoparticles, cationic lipoplexes, liposomes, hybrid materials, dendrimers, carbon nanotubes, hydrogels, quantum dots. Lipid nanoparticles (LNPs) have gained tremendous attention since US Food Drug Administration (FDA) approval Pfizer Moderna's COVID-19 raising awareness vaccines. review provides insights into current strategies issues, clinical trials. By navigating landscapes we can unlock full using range promising towards improving worldwide.

Язык: Английский

Regulatory insights into nanomedicine and gene vaccine innovation: Safety assessment, challenges, and regulatory perspectives DOI Creative Commons
Eliana B. Souto, Cristina Blanco-Llamero, Karolline Krambeck

и другие.

Acta Biomaterialia, Год журнала: 2024, Номер 180, С. 1 - 17

Опубликована: Апрель 10, 2024

This analysis explores the principal regulatory concerns linked to nanomedicines and gene vaccines, including complexities involved perspectives on how navigate them. In realm of nanomedicines, ensuring safety nanomaterials is paramount due their unique characteristics potential interactions with biological systems. Regulatory bodies are actively formulating guidelines standards assess risks associated nanomedicine products, emphasizing need for standardized characterization techniques accurately gauge effectiveness. Regarding frameworks must be tailored address distinct challenges posed by genetic interventions, necessitating special considerations in efficacy evaluations, particularly concerning vector design, target specificity, long-term patient monitoring. Ethical such as autonomy, informed consent, privacy also demand careful attention, alongside intricate matter intellectual property rights, which balanced against imperative widespread access these life-saving treatments. Collaborative efforts among bodies, researchers, patent offices, private sector essential tackle effectively, international cooperation being especially crucial given global scope vaccine development. Striking right balance between safeguarding properties promoting public health vital fostering innovation equitable ground-breaking technologies, underscoring significance addressing hurdles fully harness benefits vaccines enhancing healthcare outcomes a scale. STATEMENT OF SIGNIFICANCE: Several biomaterials proposed development nanovaccines, from polymeric micelles, PLGA-/PEI-/PLL-nanoparticles, solid lipid nananoparticles, cationic lipoplexes, liposomes, hybrid materials, dendrimers, carbon nanotubes, hydrogels, quantum dots. Lipid nanoparticles (LNPs) have gained tremendous attention since US Food Drug Administration (FDA) approval Pfizer Moderna's COVID-19 raising awareness vaccines. review provides insights into current strategies issues, clinical trials. By navigating landscapes we can unlock full using range promising towards improving worldwide.

Язык: Английский

Процитировано

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