During this Phase 1 project we performed an assessment of the feasibility of our business innovation project from different perspectives: commercial, technical/scientific and financial.
Regarding the technical feasibility after analysing the device’s regulatory frame, the strategy will be complying with GMP requirements as a prerequisite for our clients’ acceptance, thus the implementation of a Quality System is ongoing and its implementation has been fully scheduled to meet quality standards before AGLARIS commercialisation after the completion of the Phase 2 project. These QSs will also support the validation and optimization of the AGLARIS prototypes under the quality requirements. Regarding the CE-marking, we scheduled the prototype quality testing by an expert to ensure that the prototype reflects agreements on the technical description of the characteristics to be fulfilled by the prototype with the requirements outlined by the CE Directives. We can confirm that AGLARIS software works with all key functionality available for demonstration and test the cell cultivation in a fully automated manner, well integrated with operational hardware systems, demonstrating operational feasibility since most software bugs have been removed during the execution of Phase 1. Furthermore, the SW architecture allows the incorporation of additional features that could be necessary during AGLARIS’s final technology development.
Regarding commercial feasibility, we have identified stakeholders of AGLARIS’s solution along the value chain. We identified as essential using Class-VI materials for AGLARIS manufacturing and we have defined materials and component specifications/features for demanding to our potential suppliers in the EU. We have also identified suppliers for electronic and control components, flow meters, sensors, customised pieces and disposables, among others. Our research on distributors has allowed us to identify the most suitable ones. The distributors company sizes, presence at a European and international level, position within cell therapy areas and previous experience in the distribution of other bioreactors were some of the factors analysed. We have also identified AGLARIS’s potential clients within the cell therapy market that will be targeted as the most relevant. Among them, two count among the most suitable profile for being selected as the future validators of AGLARIS prototype for the next technology optimization to be performed during the Phase 2 project.
To analyse financial profitability, we have projected the 5 years’ project profitability in different scenarios (base case, pessimistic and optimistic). The 3 scenarios differ in the percentages of market penetration we might expect in the different geographical markets we are planning to enter (the EU and USA). Even in the most pessimistic scenario, the beak even is reached in the first selling year and the R.O.I (return of investment) is 284%. The base case, as the one we consider the most realistic and the base of our 5 years’ business plan, reaches break even in year two and provides an R.O.I of 295%. This means that for each euro invested in the project it seems completely realistic to achieve a profitability of 2.95€ in 5 years’ commercialization. This provides clear evidences on the AGLARIS project’s profitability.
Thus, once evaluated the possibility of applying for phase 2 we can confirm that our technology will be technically viable once validated by the identified end-users and that there is a strong market demand as reflects identified potential AGLARIS future clients. In summary, both technical and commercial issues enable us to apply for Phase 2 in the next cut-off.
