Regulatory insights into nanomedicine and gene vaccine innovation: Safety assessment, challenges, and regulatory perspectives

Acta Biomaterialia, Journal Year: 2024, Volume and Issue: 180, P. 1 - 17

Published: April 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.

Language: Английский

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Tumor microenvironment responsive multifunctional smart living materials based on engineered bacteria for inducing macrophage polarization to enhance tumor immunotherapy

Chemical Engineering Journal, Journal Year: 2024, Volume and Issue: 488, P. 150820 - 150820

Published: March 29, 2024

Language: Английский

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Emerging Cationic Nanovaccines

Pharmaceutics, Journal Year: 2024, Volume and Issue: 16(11), P. 1362 - 1362

Published: Oct. 25, 2024

Cationic vaccines of nanometric sizes can directly perform the delivery antigen(s) and immunomodulator(s) to dendritic cells in lymph nodes. The positively charged nanovaccines are taken up by antigen-presenting (APCs) lymphatic system often originating cellular immunological defense required fight intracellular microbial infections proliferation cancers. molecules imparting positive charges exhibit a dose-dependent toxicity which needs be systematically addressed. Against coronavirus, mRNA cationic evolved rapidly. Nowadays have been formulated against several with advantage compounds granting protection nucleic acids vivo biodegradation nucleases. Up threshold concentration for nanovaccine delivery, well eliciting desired Th 1 improved immune response absence cytotoxicity. A second strategy literature involves dilution components biocompatible polymeric matrixes. Polymeric nanoparticles incorporating at reduced concentrations component result an toxic effects. progress vaccinology cancer situ designs nanovaccines. lysis transformed releases tumoral antigens, presence nanoadjuvants systemically presented prevention metastatic cancer. In addition, these local allow immunotherapeutic tumor treatment.

Language: Английский

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