Optimising the manufacturing platform for individualized ips cell based heart repair

Heart failure and congenital heart defects remain among the leading causes of morbidity and mortality worldwide, with limited treatment options beyond heart transplantation or mechanical support. Autologous induced pluripotent stem cell (hiPSC)–derived cardiomyocytes (hiCMs) offer the potential to remuscularise the heart with patient-specific cells, avoiding immune rejection and lifelong immunosuppression. This is a fundamental advantage to patients’ life perspectives, broadens treatment eligibility, and is more cost-effective and sustainable long-term compared to an allogeneic approach. However, translation of autologous therapies is constrained by high initial costs, unpredictable iPSC line variability, and the lack of efficient, GMP-compatible manufacturing processes and platforms.iNDUCARE will address these challenges by optimising an FDA-approved autologous hiCM production process and embedding predictive quality and digital innovation including: (i) advanced stirred-tank bioreactor technology enabling closed-system, high-density parallel production of numerous patient-specific doses in 300 mL scale; (ii) AI-driven hybrid modelling and digital twins to stabilise hiPSC expansion and differentiation, adapting in real time to donor variability; (iii) AI-assisted genomic integrity and epigenetic QC assays linking molecular profiles to phenotypic outcomes for early triaging of unstable lines; and (iv) cost and time-efficient reprogramming with novel Sendai vectors, together laying the groundwork for affordable GMP rollout.The optimised process will be validated across two EU and one US site and benchmarked against the established workflow, generating comparable data and EMA-aligned documentation. By cutting time, cost, variability, and embedding AI-powered predictive QC, iNDUCARE will make personalised regenerative therapies affordable and clinically viable in Europe, laying the foundation for next-generation patient-specific treatments beyond cardiac repair.