Project

ENDONANO is a European Industrial Doctorates (EID) funded in the framework of H2020 Marie Skłodowska-Curie ITN programme. By merging the beneficiaries’ expertise in immunology, nanotechnology and physics into a broader approach to address toxicology and safety and related regulatory issues, the ENDONANO network aims at delivering industry-oriented PhD training of young scientists in the area of safety regulations for drugs and medical devices. In particular, ENDONANO aims at developing new concepts and methods for the unbiased and quantitative evaluation of bacterial endotoxin in complex matrices, and at laying the groundwork for developing new commercially exploitable assays thereof.

Endotoxin (lipopolysaccharide, LPS) is ubiquitous environmental contaminant coming from the Gram-negative bacterial cell membrane. Activation of innate immune cells by LPS is a major step of the defensive inflammatory response against bacteria, but excessive activation leads to a burst of inflammation and to cell death.

Safety regulations for drugs and medical devices encompass proving the absence of contamination by LPS. All available kits, of which the most common is the Limulus Amebocyte Lysate (LAL) assay, present disadvantages for detecting endotoxin or pyrogens. Indeed, in many cases the LAL assay has proven difficult to apply, since it is very sensitive to pH variations, and includes the presence of particulate matter, and several chemicals, which can interfere with the assay readout (fluorescence or optical density) or with any of the assay components (enzymes, substrates, cleaved products). This leads to generation of variable and sometimes inconclusive results, especially when formulations of inorganic nanoparticles (NP) have to be tested for endotoxin contamination due to the intrinsic chemical-physical properties of NP themselves. Thus, new more robust and reliable assays are therefore needed, which could bypass the variability and unreliability of the current LAL assays for nanomaterials and for nano-medical devices. Moreover, since NP are able to bind LPS and because of their chemical-physical properties, NP themselves can be exploited as a tool for endotoxin detection.

The scientific and technological goals of ENDONANO include: 1. Investigating the capacity of endotoxin to specifically inducing inflammatory reactions in human primary blood cells; 2. Developing new methods based on endotoxin capture by metal nanoparticles in complex matrices (biological fluids, emulsions, gels, etc.); 3. Designing and implementing signal generation and detection methods for the quantitative endotoxin measurement in NP formulations; 4. Planning assay prototypes to be developed and validated for commercial purposes.

The ENDONANO project encompasses three academic institutions with strong expertise in inflammation, advanced biosensing, and top expertise in nanotechnology and use of nanoparticles for modulating bacterial functions, two SMEs expert in development and commercialisation of diagnostic detection assays and one biotech company specialised in (magnetic) microbead technology. All have proven experience in higher education and training, and are endowed with state-of-the-art scientific and technical expertise and infrastructures.

IMPACT


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OBJECTIVES

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BACKGROUND

è un testo segnaposto utilizzato nel settore della tipografia e della stampa. Lorem Ipsum è considerato il testo segnaposto standard sin dal sedicesim