The project is structured in 8 work packages: 3 research and development, 1 translation into a prototype POC device, 2 clinical WPs for the cross-validation of the device against standard technologies and usability studies in the clinical environment (fig. 11), plus one WP for coordination and management and one for dissemination and commercialisation of the results (fig. 12).
WP 1 and 2 will start in parallel in month 1 to prepare and optimize the nanoparticles (NPs) and the separating liquid crystal (LC) phase for chemotherapeutics binding NPs. In both cases on one hand the main aim is to develop the NPs and LC for the next phase, which is the development of the single components of the microfluidic device and their characterization.
On the other hand it is planned to create knowledge matrix varying parameters like ligand chain length, functional groups for the NPs or chain length and hydrophobicity of the LC in order to facilitate the design of future device for other drugs such as epileptic drugs which needs also a tight and timely monitoring. Both WP1 and WP2 responsible for the development of the drug sensitive NPs and the separating selective LC phase will deliver to WP3 at different time points NPs to bind DOXO and its metabolites, irinotecan and its active metabolite SN-38, then methotrexate and the rescue drug leucovorin and finally NPs for paclitaxel and their respective selective LC phase separation matrix.
In WP3 the single compounds (NP, LC) will be implemented in modules, which allows to measure and process the data. The modules will be calibrated and evaluated by spiked serum samples. The partners from WP1, 2, and 3 are in permanent information exchange to optimize compatibility of NP-LC interaction and phase transfer with microfluidic environment. The optofluidic components developed in WP3 by LioniX and will then be delivered to Provenion, a SME that will implement them into an automated microfluidic device.
In parallel, the clinical partners will start to re-evaluate the stored blood samples by standard techniques or blood samples from already ongoing clinical trials. The first device will be developed for DOXO quantification and delivered to WWU for cross-evaluation. Then successively the devices will be developed for irinotecan for CRO, methotrexate again for WWU and finally for paclitaxel for CRO. In close collaboration with the clinical partners the WP1 and WP2 will evaluate selectivity of the NPs as well as the LC matrix in presence of co-medications typically used during the chemotherapy. Basing of the feedback about usability from the clinics the device will be optimized.