DataHow has been selected as a partner in iNDUCARE, a new Horizon Europe-funded project developing next-generation manufacturing solutions for autologous stem cell-based heart repair therapies.

Coordinated by Medizinische Hochschule Hannover (MHH) in Germany, iNDUCARE brings together eight organizations spanning academic, clinical, industrial, and translational research across Europe and the United States. Activities will run for four years, from September 2026 through August 2030.

Addressing an Unmet Need in Cardiac Regenerative Medicine

Heart failure and congenital heart defects remain among the world’s leading causes of illness and death, with treatment today largely limited to transplantation or mechanical support. iNDUCARE aims to change this by optimizing an FDA approved manufacturing process for autologous induced pluripotent stem cell (hiPSC) derived cardiomyocytes (hiCMs), somatic cells programmed to replace lost heart muscle cells and improve heart function.

While scientifically promising, autologous cell therapies face significant translational hurdles: high production costs, unpredictable variability between individual patient-derived cell lines, and a shortage of manufacturing platforms capable of meeting GMP standards at scale.

By combining advanced bioprocessing, AI supported quality control, and innovative manufacturing approaches, the consortium aims to increase cell yields up to sevenfold, reduce production time from one year to seven months, and cut costs by up to 70%.

The optimized process will be validated at two EU sites and one US site, benchmarked against current standard workflows, and documented in alignment with EMA regulatory expectations.

DataHow’s Role: Hybrid Modeling for Process Stability

Within the consortium, DataHow will contribute its hybrid modeling expertise to the project’s digital twin development, applying AI-driven models that combine mechanistic process knowledge with data-driven learning to help stabilize hiPSC expansion and differentiation under variable donor conditions. This work builds directly on DataHow’s decade-long focus on hybrid modeling for bioprocess development, extending the approach into the demanding, data-scarce environment of personalized cell therapy manufacturing.

By reducing process variability and enabling predictive, real-time quality control, this contribution is intended to help bring autologous cell therapies closer to affordable, clinically viable production at scale.

A Consortium Spanning the Full ATMP Value Chain

The iNDUCARE consortium includes:

• Medizinische Hochschule Hannover (MHH) — Germany (Coordinator)
• Fakultní nemocnice u sv. Anny v Brně (FNUSA) — Czech Republic
• The Hebrew University of Jerusalem — Israel
• EATRIS ERIC — Netherlands
• University of Oxford — United Kingdom
• Biothrust GmbH — Germany
• DataHow AG — Switzerland
• HeartWorks Inc. — United States

Together, the partners cover the full value chain required to bring an advanced therapy medicinal product (ATMP) from process development through clinical translation, including GMP manufacturing, AI-driven process optimization, genomic quality control, regulatory science, ethics, and clinical application.

“We’re proud to bring hybrid modeling into a consortium tackling one of the most challenging frontiers in regenerative medicine,” says Alessandro Butté, CEO at DataHow. “Personalized cell therapies are inherently data-scarce and highly variable by nature. This is exactly the kind of problem hybrid models were built to solve. We look forward to working alongside the iNDUCARE partners to help make patient-specific heart repair a clinical and commercial reality.”

About iNDUCARE

iNDUCARE (Grant Agreement No. 101288899) is funded by the European Union under the Horizon Europe program (HORIZON-HLTH-2025-01-IND-01, HORIZON Innovation Actions). More information visit  HORIZON

About DataHow

DataHow AG is a Zurich-based technology company specializing in hybrid modeling for bioprocess development. By combining mechanistic process knowledge with machine learning, DataHow’s platform, DataHowLab, helps biopharmaceutical companies accelerate process understanding, reduce experimental burden, and move toward digital, model-driven bioprocess development.