ABSTRACT
The use of nanomaterials in biomedicine has increased over the past 10 years, with many different nanoparticle systems being utilised within the clinical setting. With limited emerging success in clinical trials, polymeric, metallic, and lipid based nanoparticles have all found a place in medicine, with these generally providing enhanced drug efficacy or therapeutic effect compared to the standard drug treatments. Although there is great anticipation surrounding the field of nanomedicine and its influence on the pharmaceutical industry, there is currently very little regulatory guidance in this area, despite repeated calls from the research community, something that is critical to provide legal certainty to manufacturers, policymakers, healthcare providers and the general public. This is reflected in the lack of an international definition of what these materials are, with several bodies, including the National Institute of Health, USA, the European Science Foundation and the European Technology Platform, having differing definitions, and the FDA having no clear definition at all. The uncertainty created by the lack of consistency across the board may ultimately impact funding, research and development of such products negatively thus destroying public acceptance and perception of nano-products. This review aims to discuss the use of nanomaterials within the clinical setting, why regulation of these materials is so important, and the challenges faced in regulating these materials generally, as well as the current regulation used in different nations.
Subject(s)
Nanoparticles , Nanostructures , NanomedicineABSTRACT
With the overuse of antibiotics, many pathogens including Vibrio cholerae and Vibrio parahaemolyticus have evolved multidrug resistance making treatment more difficult. While understanding the mechanisms that underlie pathogenesis is crucial, knowledge of bacterial interactions of V. cholerae and V. parahaemolyticus could provide insight to their susceptibility outside of the human host. Based on previous work showing competition among environmental strains, we predict that marine-derived bacteria should inhibit Vibrio pathogens and may be a source of unique antibiotic compounds. We tested a collection of 3,456 environmental Vibrio isolates from diverse habitats against a panel of V. cholerae and V. parahaemolyticus, and identified 102 strains that inhibited the growth of these pathogens. Phylogenetic analysis revealed that 40 pathogen-inhibiting strains were unique at the hsp60 gene sequence while 62 of the isolates were identical suggesting clonal groups. Genomic comparisons of ten strains revealed diversity even between clonal isolates and were identified as being closely related to known Vibrio crassostreae, Vibrio splendidus, and Vibrio tasmaniensis strains. Further analysis revealed multiple biosynthetic gene clusters within all sequenced genomes that encoded secondary metabolites with potential antagonistic activity. Thus, environmental vibrios represent a source of compounds that inhibit Vibrio pathogens.
