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

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

The Application of Graphene Oxide Nanoarchitectures in the Treatment of Cancer: Phototherapy, Immunotherapy, and the Development of Vaccines.

Nanoparticles have been crucial in redesigning tumour eradication techniques, and recent advances in cancer research have accelerated the creation and integration of multifunctional nanostructures. In the fight against treatment resistance, which has reduced the effectiveness of traditional radiation and chemotherapy, this paradigm change is of utmost importance. Graphene oxide (GO) is one of several nanoparticles made of carbon that has made a splash in the medical field. It offers potential new ways to treat cancer thanks to its nanostructures, which can precisely transfer genetic elements and therapeutic chemicals to tumour areas. Encapsulating genes, protecting them from degradation, and promoting effective genetic uptake by cancer cells are two of GO nanostructures' greatest strengths, in addition to improving drug pharmacokinetics and bioavailability by concentrating therapeutic compounds at particular tumour regions. In addition, photodynamic treatment (PDT) and photothermal therapy (PTT), which use GO nanoparticles to reduce carcinogenesis, have greatly slowed tumour growth due to GO's phototherapy capabilities. In addition to their potential medical uses, GO nanoparticles are attractive vaccine candidates due to their ability to stimulate cellular and innate immunity. These nanoparticles can be used to detect, diagnose, and eradicate cancer because they respond to certain stimuli. The numerous advantages of GO nanoparticles for tumour eradication are attributed in large part to their primary route of internalisation through endocytosis, which guarantees accurate delivery to target locations. The revolutionary potential of multifunctional nanostructures in cancer treatment is highlighted in this extensive compendium that examines current oncological breakthroughs.

Revisiting microbial exopolysaccharides: a biocompatible and sustainable polymeric material for multifaceted biomedical applications.

Microbial exopolysaccharides (EPS) have gained significant attention as versatile biomolecules with multifarious applications across various sectors. This review explores the valorisation of EPS and its potential impact on diverse sectors, including food, pharmaceuticals, cosmetics, and biotechnology. EPS, secreted by microorganisms, possess unique physicochemical properties, such as high molecular weight, water solubility, and biocompatibility, making them attractive for numerous functional roles. Additionally, EPS exhibit significant bioactivity, contributing to their potential use in pharmaceuticals for drug delivery and tissue engineering applications. Moreover, the eco-friendly and sustainable nature of microbial EPS production aligns with the growing demand for environmentally conscious processes. However, challenges still exist in large-scale production, purification, and regulatory approval for commercial use. Advances in bioprocessing and microbial engineering offer promising solutions to overcome these hurdles. Stringent investigations have concluded EPS as novel sources for sustainable applications that are likely to emerge and develop, further reinforcing the significance of these biopolymers in addressing contemporary societal needs and driving innovation in various industrial sectors. Overall, the microbial EPS represents a thriving field with immense potential for meeting diverse industrial demands and advancing sustainable technologies.

Novel Approaches in the Drug Development and Delivery Systems for Age-Related Macular Degeneration.

The number of patients with ocular disorders has increased due to contributing factors such as aging populations, environmental changes, smoking, genetic abnormalities, etc. Age-related macular degeneration (AMD) is one of the common ocular disorders which may advance to loss of vision in severe cases. The advanced form of AMD is classified into two types, dry (non-exudative) and wet (exudative) AMD. Although several therapeutic approaches are explored for the management of AMD, no approved therapy can substantially slow down the progression of dry AMD into the later stages. The focus of researchers in recent times has been engaged in developing targeted therapeutic products to halt the progression and maintain or improve vision in individuals diagnosed with AMD. The delivery of anti-VEGF agents using intravitreal therapy has found some success in managing AMD, and novel formulation approaches have been introduced in various studies to potentiate the efficacy. Some of the novel approaches, such as hydrogel, microspheres, polymeric nanoparticles, liposomes, implants, etc. have been discussed. Apart from this, subretinal, suprachoroidal, and port delivery systems have also been investigated for biologics and gene therapies. The unmet potential of approved therapeutic products has contributed to several patent applications in recent years. This review outlines the current treatment options, outcomes of recent research studies, and patent details around the novel drug delivery approach for the treatment of AMD.