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 adaption
The 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.
