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Scaling Human Pluripotent Stem Cell Manufacturing

Date: 17 December 2025

Background

A client developing a patented human pluripotent stem cell (hPSC) culture medium sought to validate its performance in large-scale bioreactor systems. The goal was to demonstrate that the medium could support efficient scale-up of hPSCs while maintaining cell quality and enabling seamless technology transfer between 2D and 3D culture systems.

CCRM Nordic’s Approach

Leveraging extensive experience in hPSC manufacturing, CCRM Nordic conducted a proof-of-concept study within a Vinnova-funded project (“Nyttja infrastruktur för att utveckla precisionsmedicin”). Working closely with the client, our team provided scientific and technical guidance alongside hands-on process development. Together, we optimized a 2D/3D bioreactor protocol tailored to the client’s medium, ensuring scalability and robustness.

Results and Impact

The collaboration resulted in a verified proof-of-concept protocol for scalable hPSC culture using the client’s medium. The experimental intellectual property generated will support future development efforts. This project highlights how CCRM Nordic’s process development expertise accelerates innovation in cell culture technologies and can support early projects with their development in a relevant environment.

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