Periodic Reporting for period 1 - Quality2Cells (TimeLapseReader for Quality Control of Immune Cells used for Cell-Based Therapies) Reporting period: 2016-08-01 to 2017-01-31 Summary of the context and overall objectives of the project Cell-based therapy (CBT) for the cure of difficult-to-treat cancer types and autoimmune diseases is currently reaching an impressive momentum but there is an urgent need to determine the quality of therapeutic cells before re-transferring them into patients. With the „Quality2Cells“ project ibidi is entering a new business sector in the diagnostic market and CBT resprents a highly innovative and new therapy field. Therefore, in this feasibilty study a comprehensive research was performed to identify important CBT experts in the academic and clinical CBT field. Following activities were carried out and following results were achieved: Activities:- Identification of KOL, early adaptors and potential customers- Online survey and interviews- Market research and business plan development- Elaboration of regulatory requirements - Key parameter requirements and first specification criteria for the instrument adaptionThe feasibility study has substantiated and confirmed the technological and commercial viability and importance of the planned innovative project „Quality2Cells“. Many publications show that cell-based therapies have the potenial to make large contribution towards patients and thus effective manufacture of cell-based products is essential. However, there is an urgent need to define manufacturing requirements, including QC assessments and thus, this highly innovative project will continue.Due to the results of the feasibilty study the instrument adaption time, costs, and risks may increase compared to first assumptions. Besides T-cells, ibidi will also focus on the therapeutic cells hematopoietic stem cells (HSC) and thus, the “Quality2Cells” project will address a much bigger market size in the CBT field. All efforts will be focused to establish a complete QC solution based on the automated instrument “TimeLapseReader” in combination with ready-to-use kits, slides, and reagents. Phase 2 application is under preparation. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Following work was performed in the course of the feasibility study corresponding to the Phase 1 proposal promises:• Identification of KOL, early adaptors and potential customers for interviews and online survey.• Performance of interviews and an online survey to elaborate the application of therapeutic cells, technical features of the TLR and its adequate pricing structure. • Development of a realistic business plan, including risk assessment, competitor and FTO analysis, and market entry strategy. • Elaboration of regulatory requirements for approval by EMA and FDA.• Compiling of key parameter requirements and first specification criteria for the instrument adaption. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) Progress beyond the state of the artTaking these above-mentioned conclusions into account means that the instrument adaption time, costs, and risks may increase compared to first assumptions. However, with the additional focus on the therapeutic cells HSC the Quality2Cells project will address a much bigger market size in the CBT field. All efforts will be focused to establish a complete QC solution based on the automated instrument “TimeLapseReader” in combination with ready-to-use kits, slides, and reagents.Changes to the objectivesThere are no changes to the original objectives. During the feasibility study, it was possible to specify the projects framework and to define specific objectives for the planned Phase 2 application. The objective of the “Quality2Cells” Phase 2 project remains (i) to commercialize a complete QC solution that meets regulatory requirements and (ii) to perform all dissemination and communication activities to prepare various communities for a quick uptake into the CBT market. Expected potential impactQuality2Cells has the chance for significant reduction of inadequate CBT resulting in reduced health costs and higher safety for patients. As a direct beneficial consequence a larger number of patients can be treated with the new technologies because the risk of adverse effects is relatively lower and the chance of cure is increased. Reduction of risk and cost will support the acceptance of CBT with physicians, patients and regulatory authorities such as EMA and FDA.