iNDUCARE – Optimising the Manufacturing Platform for Individualized iPS Cell Based Heart Repair

iNDUCARE: Optimising the Manufacturing Platform for Individualized iPS Cell Based Heart Repair aims to optimise and industrialise the manufacturing of autologous induced pluripotent stem cell (hiPSC)-derived cardiomyocyte therapies for heart repair. The project addresses one of the major bottlenecks in regenerative medicine: the high cost, long timelines, variability, and limited scalability of patient-specific advanced therapy medicinal products (ATMPs). 

The project focuses on developing a clinically relevant, GMP-compliant manufacturing platform for personalised cardiac cell therapies. iNDUCARE combines advanced stirred-tank bioreactor technology, AI-driven hybrid modelling and digital twins, genomic and epigenetic quality control frameworks, and novel Sendai vector-based reprogramming technologies to improve efficiency, reproducibility, and regulatory readiness. 

By integrating automation, predictive quality control, multi-omics profiling, and GMP-ready workflows, iNDUCARE aims to substantially reduce manufacturing time and cost while increasing reproducibility and scalability. The project seeks to reduce autologous production timelines from approximately 12–18 months to 6–8 months and lower costs by up to 70%, helping make personalised regenerative therapies more clinically and economically viable in Europe. 

Consortium 

The iNDUCARE consortium brings together academic, clinical, industrial, and translational partners across Europe and internationally to cover the full ATMP value chain. Coordinated by Medizinische Hochschule Hannover (MHH), the consortium includes expertise in GMP manufacturing, AI-driven process optimisation, genomic quality control, regulatory science, ethics, and clinical translation. 

Partners include MHH (Germany), FNUSA (Czech Republic), Hebrew University of Jerusalem (Israel), EATRIS ERIC (Netherlands), University of Oxford (UK), Biothrust GmbH (Germany), DataHow AG (Switzerland), and HeartWorks Inc. (USA).  

EATRIS’ role in the project 

EATRIS supports the regulatory, translational, and health-economic dimensions of iNDUCARE, contributing expertise in regulatory science, GMP alignment, health technology assessment (HTA), and exploitation support.  

EATRIS contributes to WP6 – Enabling Frameworks and Early-Stage Outreach, where it leads regulatory landscape mapping and early dialogue with EMA and national authorities to support the project’s regulatory roadmap.  

EATRIS also leads WP7 – Mid-Stage Readiness, Societal Integration, and Dissemination, focusing on regulatory alignment, GMP-compliant process documentation, EMA Innovation Task Force engagement, and health-economic readiness of the iNDUCARE platform.  

In addition, EATRIS contributes to WP8 – Exploitation, Market Readiness, and Final Impact Pathways, leading activities related to health economics and HTA to support affordability, sustainability, and future implementation of decentralised autologous ATMP manufacturing.