Periodic Reporting for period 1 - NANOFLOWSIZER (Developing a disruptive and revolutionary tool for real time inline nanoparticle size measurement, for superior quality control and process efficiency.)
Período documentado: 2019-03-01 hasta 2019-06-30
We are developing the NanoFlowSizer (NFS), an inline nanoparticle size analyser. Size measurement is essential for quality control process in the production and manufacturing of nanoparticles. Currently, the technology of choice is Dynamic Light Scattering (DLS). However, DLS does not allow in-line measurement. It requires extracting a sample from the production line and sample preparation prior to analysis. The associated problems produce poor quality control that leads to batch rejection rates of 10-15%.
Technical feasibility: We have assessed the steps to comply with the GMP guidelines in software development and elaborated a roadmap for optimizing our optical unit. This optimization will facilitate a reduction in the manufacturing costs and extension of applications. We will involve instrumentation developers who fulfil requirements set in this study. The necessary work to be done has been implemented in a work plan.
Commercial feasibility: There is large potential within the particle size analysis market, which offers various opportunities to NFS. We have established the end-users and analysed the risks of the action, minimized by the designed mitigation strategy. The market segmentation shows that the most profitable strategy is to initially focus on the pharma market, with US and Europe as targets. There are no inline solutions in the market, there are no inline solutions, offering opportunities for a new niche market. We have elaborated the roadmap to obtain the CE marking and defined our commercial strategy (direct sales). We have also defined our dissemination strategy, established our freedom to operate and devised our IPR strategy.
Financial feasibility: We are close to closing a deal with an investor consortium. We have established the budget for the project and carried out 5-year financial projections based on the different NFS revenue streams. The resulting return on investment shows that the NFS is a very profitable endeavour.
Business Plan: We have been able to carry out a SWOT analysis of the business plan for NFS. The main conclusion is that the NFS is a feasible project and, therefore, we will pursue Phase 2.
Commercial feasibility: There is large potential within the particle size analysis market, which offers various opportunities to NFS. We have established the end-users and analysed the risks of the action, minimized by the designed mitigation strategy. The market segmentation shows that the most profitable strategy is to initially focus on the pharma market, with US and Europe as targets. There are no inline solutions in the market, there are no inline solutions, offering opportunities for a new niche market. We have elaborated the roadmap to obtain the CE marking and defined our commercial strategy (direct sales). We have also defined our dissemination strategy, established our freedom to operate and devised our IPR strategy.
Financial feasibility: We are close to closing a deal with an investor consortium. We have established the budget for the project and carried out 5-year financial projections based on the different NFS revenue streams. The resulting return on investment shows that the NFS is a very profitable endeavour.
Business Plan: We have been able to carry out a SWOT analysis of the business plan for NFS. The main conclusion is that the NFS is a feasible project and, therefore, we will pursue Phase 2.
We aim at producing NFS 2.0 with improved functionality and performance. We will develop and implement GMP compliant version of the software. This will allow for high-performance quality control, essential in the highly regulated pharmaceutical industry: adequate particle size control ensures correct product functionality, efficacy and safety for the patients.